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DTSTART;TZID=America/Los_Angeles:20221005T110000
DTEND;TZID=America/Los_Angeles:20221005T114500
DTSTAMP:20221006T215640Z
CREATED:20220921T184401Z
LAST-MODIFIED:20221006T215640Z
UID:3893-1664967600-1664970300@criterionedge.com
SUMMARY:Ask the Expert: Clinical Evaluation Report Critical Concepts
DESCRIPTION:Ask the Expert: Clinical Evaluation Report Template and Critical Concepts\nThis session is presented from the point of view of seasoned MDR-compliant CER medical writers. In this 45-minute live Q&A\, we will answer questions regarding critical concepts for a clinical evaluation report template such as safety and performance objectives\, clinical outcomes\, clinical benefits\, acceptance criteria\, and risk-benefit ratio. We hope to provide you with best practices and writing strategies to support solid planning during your own writing process. \nDuring this session\, come prepared with your questions for our experts to answer. Please submit your questions ahead of time while registering for this session so we have ample time to answer them thoughtfully. Also\, please be aware that answers will be limited to 3 minutes per question. \nThis forum will answer questions on a first come first serve basis\, so please submit all your questions when you register for this event. \nClick here to watch the recording of this session. \nWho is this session for?\nThose Regulatory\, Quality and Clinical leaders and teams who develop\, write\, review\, or approve clinical evaluation reports for MDR submissions or performance evaluation reports for IVDR submissions. \nHow to Deploy Systematic Literature Review in Order to Augment Post Market Clinical Surveillance\nAre you looking for best tips on how to create a robust systematic literature review process? And maybe even an informative case study illustrating the process? Watch our webinar on effective systematic literature review for post-market surveillance to understand how to continually support your device once your clinical evaluation report is completed and submitted. Learn how leveraging published data can help meet regulatory expectations and inform internal decision-making​\, the steps for conducting a methodologically-sound SLR​\, and even how data obtained through SLR can empower the successful execution of post-market surveillance activities\, drive efficiencies\, and support regulatory compliance. \nKey Strategies to Support Project Success: The Clinical Evaluation Report Template\nDo you know how to identify meaningful safety and performance endpoints (measures/objectives)? Are you confidently able to demonstrate that your safety and performance objectives are appropriate and clinically relevant? \nDownload our free white paper\, a companion piece to our popular webinar where we cover strategies to verify device safety and performance in the clinical evaluation of medical and in vitro diagnostic (IVDs) devices. This white paper should help you with identifying meaningful safety and performance measures for clinical or performance evaluation. It will also help with defining acceptance criteria parameters to determine the acceptability of benefit-risk as mandated by Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Regulation (IVDR) 2017/746.
URL:https://criterionedge.com/event/ask-the-expert-clinical-evaluation-report-critical-concepts/
LOCATION:Virtual Q&A
CATEGORIES:MDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/ATE-CER-Critical-Concepts-cover-100522.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20220928T110000
DTEND;TZID=America/Los_Angeles:20220928T120000
DTSTAMP:20220929T213552Z
CREATED:20220916T221535Z
LAST-MODIFIED:20220929T213552Z
UID:3883-1664362800-1664366400@criterionedge.com
SUMMARY:CER Critical Concepts
DESCRIPTION:Clinical Evaluation Report Critical Concepts: Effectively Telling the Story of the CER – Focus on S&P Objectives\, Acceptance Criteria\, Clinical Benefits and Risk-Benefit Analysis\nSafety and performance objectives…..clinical outcomes…..clinical benefits…..acceptance criteria…..risk-benefit ratio. These terms represent key concepts of the Clinical Evaluation Report (CER)\, yet confusion still exists on how to effectively identify\, present and analyze these parameters within the context of an MDR-compliant CER. How do they tie together? How do they help you “tell the story” of the CER? \nClick here to watch the recording of this session. \nPresented from the point of view of seasoned MDR-compliant CER medical writers\, this session will take a practical approach to: \n\nDefine each of these concepts and their relationship to each other\nDevelop MDR-aligned safety and performance objectives\nHow clinical outcomes are leveraged in the CER and how they are different from S&P objectives\nTying it all together in the Risk-Benefit section of the CER (hint: this section is where it all comes together)\n\nThere will be time at the end of this session to ask questions. Please submit your questions ahead of time while registering for this session so we have ample time to answer them thoughtfully. You may choose to send in your questions during the presentation as well. \nWho is this forum for?\nThose Regulatory\, Quality and Clinical leaders and teams who develop\, write\, review\, or approve clinical evaluation reports for MDR submissions. Anyone interested in learning more about MDR requirements for CERs is also welcome to attend. Also\, we encourage professionals from the IVD industry to attend as well\, as the content is also relevant to IVDR requirements\, which align closely with MDR. \nCritical Concepts: Measurable Objectives and Acceptance Criteria\nThis white paper is a companion piece to our popular webinar where we cover strategies to verify device safety and performance in the clinical evaluation of medical and in vitro diagnostic (IVDs) devices. This white paper should help you with identifying meaningful safety and performance measures for clinical or performance evaluation and with defining acceptance criteria parameters to determine the acceptability of benefit-risk as mandated by Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Regulation (IVDR) 2017/746. \nEstablishing your device’s safety and performance is a critical component of the clinical evaluation process. However\, how to use the state of the art section within the Clinical Evaluation Report (CER) and Performance Evaluation Report (PER) to establish the device’s safety and performance objectives and acceptance criteria can seem ambiguous. \nDownload the full white paper here.
URL:https://criterionedge.com/event/cer-critical-concepts/
LOCATION:Webinar\, United States
CATEGORIES:MDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/CER-Critical-Concepts-cover-090722.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20220831T110000
DTEND;TZID=America/Los_Angeles:20220831T120000
DTSTAMP:20220903T163317Z
CREATED:20220903T163317Z
LAST-MODIFIED:20220903T163317Z
UID:3854-1661943600-1661947200@criterionedge.com
SUMMARY:Demonstration of Sufficient Evidence and Regulatory Strategy Alignment in the Clinical Evaluation Process
DESCRIPTION:Demonstration of Sufficient Evidence and Regulatory Strategy Alignment in the Clinical Evaluation Process \nIn the first part of our webinar series\, we discussed Legacy Devices\, WET devices\, and devices exempt from Clinical Investigations under Article 61\, along with the need for data sufficiency and how significant changes impact the route to conformity. In this webinar\, our medical regulatory experts\, Dr. Sarah Chavez and Stacie Beecham\, discuss the concept of data sufficiency and give you strategies for addressing limited clinical and performance data. We also discuss adjusting the Clinical Evaluation Plan to align with the regulatory strategy.  How do you determine which content applies to each classification? How do you address data insufficiency for a WET or Legacy device? We answer these questions and outline how to ensure your regulatory strategy will adequately support the clinical evaluation specific to your device. \nClick here to watch the recording of this webinar. \nWho should register for this webinar?\nThose Regulatory\, Quality and Clinical leaders and teams who develop\, write\, review\, or approve clinical evaluation reports for MDR submissions\, or anyone interested in learning more about these requirements. Those from the IVD space are welcome to attend as this information may also be relevant. \nHow to Empower Data-Driven Decisions in Your Organization\nEvery day\, pharma and medical device companies need data from Systematic Literature Reviews (SLRs) to inform\, direct\, and help drive their internal processes and decisions. Of course\, to comply with global regulatory requirements\, clinical literature is also required. Conducting SLRs to search\, screen\, and extract data from published sources can present challenges to your team in terms of expertise (e.g.\, medical librarian)\, methodology\, and resources. It takes trained people with the availability to screen\, review\, and analyze the literature. \nDownload our free white paper\, Systematic Literature Review: How to Empower Data-Driven Decisions in Your Organization to read more on this topic. \nYou can also watch our webinar on this topic. \nOur President Laurie Mitchell joins Jennifer Tetzlaff\, Research Product Specialist with Evidence Partners\, to talk to you about the following points: \n\nExamples of how the use of published data can support regulatory expectations\nWhen to conduct a systematic literature review\nBest practices for conducting a methodologically-sound SLR\nUse of available tools and technology
URL:https://criterionedge.com/event/demonstration-of-sufficient-evidence-and-regulatory-strategy-alignment-in-the-clinical-evaluation-process/
LOCATION:Webinar\, United States
CATEGORIES:MDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/cover-without-date-Demonstration-of-Sufficient-Evidence-1.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20220803T110000
DTEND;TZID=America/Los_Angeles:20220803T120000
DTSTAMP:20220902T191940Z
CREATED:20220728T224501Z
LAST-MODIFIED:20220902T191940Z
UID:3777-1659524400-1659528000@criterionedge.com
SUMMARY:Bridging the Gaps: Clinical Data for GSPRs
DESCRIPTION:Bridging the Gaps: Determining Clinical Data Sufficiency to Demonstrate Conformity with GSPRs\nWhat do I do if there is no data for my device? This is a concern we hear quite often from clients. MDR states that device groups may not require clinical investigations if sufficient clinical evidence exists and the device meets specific criteria. In this webinar\, we will discuss the concept of clinical data sufficiency. Specifically\, we will explain the differences between a well-established technology and a legacy device as defined by MDR\, and discuss strategies from both a regulatory and writer’s perspective. \nClick here to watch the recording of this webinar. \nThere will be time at the end of the webinar to get your questions answered. Please submit any questions ahead of time while registering for this session so we have ample time to answer them thoughtfully. You may also send in your questions during the webinar. \nWho should register for this webinar?\nThose Regulatory\, Quality and Clinical leaders and teams who develop\, write\, review\, or approve clinical evaluation reports for MDR submissions\, or anyone interested in learning more about these requirements. Those from the IVD space are welcome to attend as this information may also be relevant. \nHow to Empower Data-Driven Decisions in Your Organization\nEvery day\, pharma and medical device companies need data from Systematic Literature Reviews (SLRs) to inform\, direct\, and help drive their internal processes and decisions. Of course\, to comply with global regulatory requirements\, clinical literature is also required. Conducting SLRs to search\, screen\, and extract data from published sources can present challenges to your team in terms of expertise (e.g.\, medical librarian)\, methodology\, and resources. It takes trained people with the availability to screen\, review\, and analyze the literature. \nDownload our free white paper\, Systematic Literature Review: How to Empower Data-Driven Decisions in Your Organization to read more on this topic. \nYou can also watch our webinar on this topic. \nOur President Laurie Mitchell joins Jennifer Tetzlaff\, Research Product Specialist with Evidence Partners\, to talk to you about the following points: \n\nExamples of how the use of published data can support regulatory expectations\nWhen to conduct a systematic literature review\nBest practices for conducting a methodologically-sound SLR\nUse of available tools and technology
URL:https://criterionedge.com/event/bridging-the-gaps-clinical-data-for-gsprs/
LOCATION:Webinar\, United States
CATEGORIES:MDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/bridging-the-gaps-clinical-data-for-GSPRs-webinar-cover-080322.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20220713T110000
DTEND;TZID=America/Los_Angeles:20220713T114500
DTSTAMP:20220722T200430Z
CREATED:20220627T202106Z
LAST-MODIFIED:20220722T200430Z
UID:3739-1657710000-1657712700@criterionedge.com
SUMMARY:ATE: The Role of RA in the Clinical and Performance Evaluation Process
DESCRIPTION:Ask the Expert: The Role of Regulatory Affairs in the Clinical and Performance Evaluation Process\nRegulatory Affairs is poised to play a critical role in supporting the current MDR and IVDR required clinical and performance evaluation process\, from project implementation through report writing and finally\, the on-time submission to the notified body. In this session\, we answer questions from many stages of the writing process\, from the early planning stage through completion of all required written deliverables. Topics include early assessment of data sufficiency\, equivalence considerations\, internal readiness of critical documentation\, project planning strategies\, or how to identify potential roadblocks and proactively find solutions to common problems. \nClick here to watch the recording of this session. \nWho should watch this session?\nThose Regulatory\, Quality and Clinical leaders and teams who develop\, write\, review\, or approve clinical evaluation reports for MDR submissions or performance evaluation reports for IVDR submissions. \nThinking about using an outsourced regulatory writing team\, but aren’t sure of the advantages?\nIn today’s medical device and pharmaceutical environment\, it’s imperative to analyze and present complex information clearly and concisely while meeting critical timelines. Partnering with team of experienced regulatory writers can be a beneficial alternative to maintaining an in-house writing staff. \nRead our blog post to help decide if outsourcing is the right decision for your team. \nKey Strategies to Support Project Success for the Clinical and Performance Evaluation Process\nDo you know how to identify meaningful safety and performance endpoints (measures/objectives)? Are you confidently able to demonstrate that your safety and performance objectives are appropriate and clinically relevant? \nDownload our free white paper\, a companion piece to our popular webinar where we cover strategies to verify device safety and performance in the clinical evaluation of medical and in vitro diagnostic (IVDs) devices. This white paper should help you with identifying meaningful safety and performance measures for clinical or performance evaluation. It will also help with defining acceptance criteria parameters to determine the acceptability of benefit-risk as mandated by Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Regulation (IVDR) 2017/746.
URL:https://criterionedge.com/event/the-role-of-ra-in-the-clinical-and-performance-evaluation-process/
LOCATION:Virtual Q&A
CATEGORIES:IVDR Webinars,MDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/ATE-The-role-of-RA-cover-071322.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20220620
DTEND;VALUE=DATE:20220625
DTSTAMP:20220524T235048Z
CREATED:20220331T215612Z
LAST-MODIFIED:20220524T235048Z
UID:3484-1655683200-1656115199@criterionedge.com
SUMMARY:Medtech Summit
DESCRIPTION:Join us at Medtech Summit in Dublin\, Ireland\nCriterion Edge provides medical and regulatory writing services for the medical device industry and will be attending Medtech Summit in Dublin\, Ireland\, from June 20-24. Our specialists will be on site at the convention ready to meet you and your team to discuss your writing or project needs. \nWe’re excited to be sponsoring MedTech Summit 2022! Join us and get 10% off* your pass with our discount code MTCH22SPO. You can register here if you haven’t already. The summit is hybrid\, so if you’d like to be a part of the digital experience only\, you can sign up for the digital pass. Explore the full 2022 MedTech Summit agenda here. \nCriterion Edge supports medical device companies like the ones attending with the production of the required MDR submissions. These include\, but are not limited to\, clinical evaluations reports (CER) and plans (CEP)\, clinical performance reports (CPR)\, post-market clinical follow-up (PMCF) plans and reports\, post-market surveillance (PMS) reports\, PSURs and summary of safety and clinical performance (SSCP)\, and systematic literature reviews. Read more about us here. \nIf you’re attending\, let’s schedule time to meet in person at the event. If you can’t make it to the conference\, we’d still like to meet and chat with you and/or a colleague at a time that works for you. Book a convenient time to speak with us here.
URL:https://criterionedge.com/event/medtech-summit-june-20-24-dublin/
LOCATION:Clayton Hotel Burlington Road\, Leeson Street Upper\, Dublin\, D04 A318\, Ireland
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/medtech-summit-sponsor-social-media-banner.png
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20220615T110000
DTEND;TZID=America/Los_Angeles:20220615T120000
DTSTAMP:20220616T005819Z
CREATED:20220602T195713Z
LAST-MODIFIED:20220616T005819Z
UID:3622-1655290800-1655294400@criterionedge.com
SUMMARY:The Role of RA in the Clinical and Performance Evaluation Process
DESCRIPTION:The Role of Regulatory Affairs in the Clinical and Performance Evaluation Process: Key Strategies to Support Project Success\nRegulatory Affairs plays a critical role in supporting the current MDR and IVDR required clinical/performance evaluation process\, from project implementation through report writing and finally\, the on-time submission to the notified body. From the early planning stage through completion of all required written deliverables\, this presentation examines key drivers of project success\, such as early assessment of data sufficiency\, equivalence considerations\, internal readiness of critical documentation\, project planning strategies\, and how to identify potential roadblocks and proactively find solutions to common problems. \nClick here to watch the recording of this webinar. \nKey Takeaways:\n1. Identify critical components of the clinical evaluation process and strategies to support project success. \n2. Describe how Regulatory Affairs can support cross-functional stakeholders and lead critical decision-making throughout the clinical evaluation process. \n3. Recognize and implement early mitigation strategies to overcome roadblocks and drive to on-time submission. \nThere will be time at the end of the presentation to get your questions answered. Please submit your questions ahead of time while registering for this session so we have ample time to answer them thoughtfully. Also\, answers will be limited to 3 minutes per question. \nWho should register for this webinar?\nThose Regulatory\, Quality and Clinical leaders and teams who develop\, write\, review\, or approve clinical evaluation reports for MDR submissions or performance evaluation reports for IVDR submissions. \nThinking about using an outsourced regulatory writing team\, but aren’t sure of the advantages?\nIn today’s medical device and pharmaceutical environment\, it’s imperative to analyze and present complex information clearly and concisely while meeting critical timelines. Partnering with team of experienced regulatory writers can be a beneficial alternative to maintaining an in-house writing staff. \nRead our blog post to help decide if outsourcing is the right decision for your team. \nKey Strategies to Support Project Success for the Clinical and Performance Evaluation Process\nDo you know how to identify meaningful safety and performance endpoints (measures/objectives)? Are you confidently able to demonstrate that your safety and performance objectives are appropriate and clinically relevant? \nDownload our free white paper\, a companion piece to our popular webinar where we cover strategies to verify device safety and performance in the clinical evaluation of medical and in vitro diagnostic (IVDs) devices. This white paper should help you with identifying meaningful safety and performance measures for clinical or performance evaluation. It will also help with defining acceptance criteria parameters to determine the acceptability of benefit-risk as mandated by Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Regulation (IVDR) 2017/746.
URL:https://criterionedge.com/event/strategies-to-support-project-success-in-the-clinical-and-performance-evaluation-process/
LOCATION:Webinar\, United States
CATEGORIES:IVDR Webinars,MDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/the-role-of-RA-webinar-cover-061522.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20220601T110000
DTEND;TZID=America/Los_Angeles:20220601T120000
DTSTAMP:20220602T200132Z
CREATED:20220512T170649Z
LAST-MODIFIED:20220602T200132Z
UID:3576-1654081200-1654084800@criterionedge.com
SUMMARY:Scoping Your MDR & IVDR Writing Projects
DESCRIPTION:Scoping Your MDR and IVDR Writing Projects – The Forgotten Step\nIn most of our webinars\, we’ve focused on the writing process including which steps to take and how to organize your thoughts onto paper. However\, we’ve never discussed what happens before the writing process begins. So what do you need before you get started? \nIn this webinar\, we’ll discuss the process of scoping a writing project for either MDR or IVDR. We will share the key questions we ask our clients before we start writing and what key inputs are necessary to kickstart the project and ensure you’re starting on the right foot. \nWe hope to \n\nGive insight into planning realistic timelines and assessing your team’s bandwidth to complete your project\nProvide examples of key documents and inputs needed early in the writing process\nDescribe where these pieces fit within the Clinical Evaluation Report or Performance Evaluation Report templates\n\nWho is this forum for?\nThose regulatory\, quality and clinical leaders and teams who are tasked with the development\, writing\, review\, or approval of Clinical Evaluation Reports for MDR submissions or Performance Evaluation Reports for IVDR submissions. Anyone interested in learning more about the requirements for these reports is also welcome to attend. \nClick here to watch the recording of this webinar. \n6 Project Management Secrets Used by Top Medical Writers\nI bet when you became a medical writer\, you didn’t imagine most of your time would be spent on managerial tasks that don’t involve writing at all. According to one prominent medical writing consultant\, most medical writers spend 60% of their time on writing and 40% on project management. As you have likely discovered\, the skills required of today’s medical writers go beyond subject matter and regulatory expertise. Given the size and scope of most medical writing projects\, this is no surprise. If you find yourself overwhelmed by the project management oversight needed for large projects and overlapping projects involving multiple writers\, you’re not alone. \nClick here to read these six key tactics to ensure your next medical writing job runs smoothly and meets the necessary requirements. \nAt Criterion Edge\, our clients enjoy our transparency in the services we provide as our candid scoping includes a time frame for delivering the CER and detailed information on gaps in compliance. All of our writers have experience writing CERs and are up to date on current regulations. Providing a comprehensive analysis and subsequent solutions sets us apart from other vendors. Contact us if you would like to have a conversation about what we can do to help with your writing and regulatory needs. 
URL:https://criterionedge.com/event/scoping-your-mdr-ivdr-writing-projects/
LOCATION:Webinar\, United States
CATEGORIES:IVDR Webinars,MDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/Scoping-Your-MDR-and-IVDR-Projects-060122.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20220518T110000
DTEND;TZID=America/Los_Angeles:20220518T114500
DTSTAMP:20220520T174735Z
CREATED:20220428T050347Z
LAST-MODIFIED:20220520T174735Z
UID:3535-1652871600-1652874300@criterionedge.com
SUMMARY:Ask the Writers
DESCRIPTION:Ask the Writers: A Comparison of Critical Elements of the Scientific Validity Report vs. the CER State-of-the-Art and Best Practice Writing Strategies\nIn this highly interactive question-and-answer session\, Criterion Edge experts Laurie Mitchell\, President\, and Dr. Sarah Chavez\, Director of IVD and Scientific Writing Services\, will outline the must-have elements for two very similar regulatory reports: the State-of-the-Art section of an EU MDR-compliant Clinical Evaluation Report (CER) and the EU IVDR Scientific Validity Report (SVR). \nParticipants will understand the required and critical content that is common to both documents and learn best-practice writing strategies to support successful completion of these challenging projects. Come with your questions ready to get feedback from our experts! \nPlease submit your questions ahead of time while registering for this session so we have ample time to answer them thoughtfully. Also\, please be aware that answers will be limited to 3 minutes per question. \nThis forum will answer questions on a first come first serve basis\, so please submit all your questions when you register for this event. \nWho is this forum for?\nThose regulatory\, quality and clinical leaders and teams who are tasked with the development\, writing\, review\, or approval of Clinical Evaluation Reports for MDR submissions or Scientific Validity Reports for IVDR submissions. Anyone interested in learning more about the requirements for these reports is also welcome to attend. \nClick here to watch the recording of this session. \nWhy is it important to establish state of the art during the clinical evaluation?\nThe large number of mentions of state of the art throughout MEDDEV 2.7/1 rev 4 provide not only a comprehensive description of the importance\, purpose\, and role of establishing the state of the art\, but also inform on how to incorporate this analysis into the clinical evaluation. The image below summarizes several core roles of this analysis. \nEstablishing and describing state of the art is not an isolated task\, but is central to the entire clinical evaluation. Defining the current\, accepted best treatment options\, and describing the risks and benefits of these options\, provides essential information for multiple aspects of the clinical evaluation. Thus\, establishing state of the art yields information that is essential for determining if the safety and performance of a device is compatible with current standards (in comparison to available treatment options). In other words\, state of the art establishes a reference standard that is used throughout the clinical evaluation. \nIf you want to find out more about State of the Art according in MEDDEV 2.7/1 rev 4\, you can download our full whitepaper.
URL:https://criterionedge.com/event/ask-the-writers-critical-elements-of-the-scientific-validity-report/
LOCATION:Virtual Q&A
CATEGORIES:IVDR Webinars,MDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/Ask-the-Writers-SVR-and-CER-webinar-cover-051822.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20220510
DTEND;VALUE=DATE:20220513
DTSTAMP:20220511T214917Z
CREATED:20220511T214917Z
LAST-MODIFIED:20220511T214917Z
UID:3572-1652140800-1652399999@criterionedge.com
SUMMARY:RAPS Euro Convergence
DESCRIPTION:Join us at RAPS Euro Convergence in Amsterdam\, Netherlands\nCriterion Edge provides medical and regulatory writing services for the medical device\, pharmaceutical\, and in vitro diagnostics industries and will be attending RAPS Euro Convergence in Amsterdam\, from May 10-12. Our specialists will be on site at the conference ready to meet you and your team to discuss your writing or project needs. Stop by our booth for a chance to win a cool travel accessory each day. \nYou can register here if you haven’t already. Explore the full 2022 convergence agenda here. \nCriterion Edge supports medical device companies like the ones attending with the production of the required MDR submissions. These include\, but are not limited to\, clinical evaluations reports (CER) and plans (CEP)\, clinical performance reports (CPR)\, post-market clinical follow-up (PMCF) plans and reports\, post-market surveillance (PMS) reports\, PSURs and summary of safety and clinical performance (SSCP)\, and systematic literature reviews. Read more about us here. \nIf you’re attending\, let’s schedule time to meet in person at the event. If you can’t make it to the conference\, we’d still like to meet and chat with you and/or a colleague at a time that works for you. Book a convenient time to speak with us here.
URL:https://criterionedge.com/event/raps-euro-convergence-2022/
LOCATION:Park Inn by Radisson Amsterdam City West\, Netherlands
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20220428T110000
DTEND;TZID=America/Los_Angeles:20220428T114500
DTSTAMP:20220520T174942Z
CREATED:20220324T235600Z
LAST-MODIFIED:20220520T174942Z
UID:3442-1651143600-1651146300@criterionedge.com
SUMMARY:[Ask the Expert] Common Notified Body Review Findings
DESCRIPTION:This session’s topic: Tips For How to Avoid Common Notified Body Review Findings\nCriterion Edge is often approached by clients with MDR Clinical Evaluation Reports (CERs) that require extensive revisions based upon Notified Body review and feedback.  Addressing NB feedback costs your team time and effort and may threaten critical submission deadlines. However many of these issues might have been avoidable with thorough pre-planning\, proper project scoping and asking the right questions from the beginning.  In this “Ask the Expert” question-and-answer session\, we will show you some of the most common issues our writing team encounters with clients who face these revisions and discuss how they can be avoided. Presented from the perspective of experienced medical writers\, we hope to provide examples of how solid planning during your own writing process can help you avoid the most common missteps in your own CER or PER. \nDuring this 45-minute session\, come prepared with your questions for our experts to answer regarding your notified body review findings. Please submit them ahead of time while registering so we have ample time to answer them thoughtfully. Also\, please be aware that answers will be limited to 3 minutes per question. \nThis forum will answer questions on a first come first serve basis\, so please submit all your questions when you register for this event. \nWho is this forum for?\nThose Regulatory\, Quality and Clinical leaders and teams who develop\, write\, review\, or approve clinical evaluation reports for MDR submissions or performance evaluation reports for IVDR submissions. \nClick here to watch the recording of this session. \n“Unachievable Deadlines” – The EU’s Team-NB Calls for New Guidance on Allowing Remote Audits\nNotified Bodies (NBs) across Europe along with global manufacturers are facing resource constraints. The cause? Additional requirements imposed by the new MDR/IVDR Regulations. Team-NB\, the European notified body association\, issued a position paper to express concerns about lack of resources and guidance to assist in meeting the certification deadlines. \nThe primary concern cited is the likely device shortage for patients. More complex and longer certification processes required under MDR/IVDR are influencing this shortage. In conjunction\, the demands are too great for the small number of MDR/IVDR designated Notified Bodies (NBs). With only 25 NBs for MDR and 6 for IVDR\, the demand outweighs supply. Compared with 51 NBs designated for MDD and 21 under the AIMDD/IVDD Directives\, manufacturers are in a tough situation now compared to years prior. \nTeam-NB identified the following four primary contributing factors\, summarized in our recent blog post here.
URL:https://criterionedge.com/event/ask-the-expert-tips-to-avoid-common-notified-body-review-findings/
LOCATION:Virtual Q&A
CATEGORIES:IVDR Webinars,MDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/ATE-Notified-Body-review-findings-cover-042822.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20220423T080000
DTEND;TZID=America/Los_Angeles:20220426T170000
DTSTAMP:20220331T215853Z
CREATED:20220331T215853Z
LAST-MODIFIED:20220331T215853Z
UID:3458-1650700800-1650992400@criterionedge.com
SUMMARY:Annual European Congress of Clinical Microbiology & Infectious Diseases
DESCRIPTION:Join us at the ECCMID in Lisbon\, Portugal\nCriterion Edge provides medical and regulatory writing services for the in vitro diagnostics (IVD) industry and will be attending the 32nd European Congress of Clinical Microbiology & Infectious Diseases in Lisbon\, Portugal\, from April 23-26\, 2022. President\, Laurie Mitchell\, will be on site at the convention ready to meet you and your team. \nYou can register here if you haven’t already. \nCriterion Edge supports in-vitro diagnostic device companies like the ones attending with the production of the required IVDR submissions. These include\, but are not limited to\, performance evaluations report (PER)\, scientific validity report (SVR)\, clinical performance report (CPR)\, performance evaluation plan (PEP)\, and systematic literature reviews. Read more about us here. \nIf you’re attending\, let’s schedule time to meet in person at the event. Can’t make it to the conference? We’d still like to meet and have a chat with you and/or a colleague at a time that works for you. Book a convenient time to speak with us here.
URL:https://criterionedge.com/event/annual-european-congress-of-clinical-microbiology-infectious-diseases/
LOCATION:FIL – FEIRA INTERNACIONAL DE LISBOA\, Edificio FIL\, Rua do Bojador\, Parque das Nações\, Lisbon\, 1998-010\, Portugal
ORGANIZER;CN="ESCMID":MAILTO:eccmidregistration[@escmid.org
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20220420T110000
DTEND;TZID=America/Los_Angeles:20220420T120000
DTSTAMP:20220520T175031Z
CREATED:20220301T235059Z
LAST-MODIFIED:20220520T175031Z
UID:3375-1650452400-1650456000@criterionedge.com
SUMMARY:How to Establish the Competitive Landscape Within the Scientific Validity Report
DESCRIPTION:In this practical presentation\, Dr. Sarah Chavez\, will present a detailed outline of the IVDR State of the Art search within the Performance Evaluation Report (PER). Additionally\, she will distinguish between the purpose and scope of the state-of-the-art and the Competitor search. For example\, the SLR approach\, data screening\, and data presentation will be addressed. \nYou will learn:\n\nThe importance of the SOA SLR for providing background and general information\nHow to establish acceptance criteria with data\nHow to assess the safety and performance of your IVD with a systematic approach to the Competitor SLR process\n\nWho should attend?\nThose Regulatory\, Quality and Clinical leaders and teams who develop\, write\, review or approve Performance Evaluation Reports for EU IVDR submission. Also\, anyone interested in learning more about the competitive landscape within the Scientific Validity Report should attend. \nClick here to watch the webinar recording. \nIVDR Essentials: Performance Evaluation Report – Early Planning and Preparation\nHow can scoping help you identify critical internal documents needed for IVDR readiness? What are the benefits to beginning the process early? There are many moving pieces needed to write a PER\, so we have developed strategies to keep you and your team on track and help assess your own level of preparedness. Using our CE Scoping checklist\, we will walk through the necessary documents\, SOPs\, processes\, reports\, and templates\, and explain how each of these fits into the overall process of preparing to write. \nThis presentation will emphasize the importance of scoping\, discuss how to develop a checklist\, and illustrate how scoping may help you identify gaps or missing pieces that could lead to delays or challenges in your PER writing process. \nWatch the free webinar recording now.
URL:https://criterionedge.com/event/how-to-establish-the-competitive-landscape-within-the-scientific-validity-report-2/
LOCATION:Webinar\, United States
CATEGORIES:IVDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/establish-the-competitive-landscape-cover-slide-042022.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20220330T110000
DTEND;TZID=America/Los_Angeles:20220330T120000
DTSTAMP:20220330T223102Z
CREATED:20220216T200837Z
LAST-MODIFIED:20220330T223102Z
UID:3339-1648638000-1648641600@criterionedge.com
SUMMARY:IVD Deep Dive Series Part 2
DESCRIPTION:Clinical Data Sources: Leveraging Clinical Data in the Clinical Performance Report\nIn Part 1 of our IVD Deep Dive series\, we discussed the importance of selecting meaningful performance objectives and explained how these objectives help establish the acceptance criteria. Part 2 of our series will pick up from there with strategies to identify sources of clinical data for your IVD. \nPresented from the point of view of seasoned MDR-compliant CER medical writers\, this session will present strategies for the verification of IVD clinical performance in the PER. This presentation should help you identify meaningful and measurable performance measures and identify sources of clinical data to support the Clinical Performance Report (CPR). \nKey Takeaways: \n\nDiscuss the purpose of the CPR and its role as a critical component of the PER\nIdentify sources of clinical data and analyze those data within the context of the\nperformance endpoints and acceptance criteria presented in the SVR\nDemonstrate how to extract\, organize\, and appraise these data within the CPR\n\nWatch the webinar recording. \nWho should watch this webinar?\nThose Regulatory\, Quality and Clinical leaders and teams who develop\, write\, review\, or approve clinical performance reports for IVDR submissions. \n  \nKey Changes in the Regulatory Requirements for In Vitro Diagnostic Devices Marketed in the European Union Under IVDR 2017/746\nIn vitro diagnostic (IVD) medical devices in the European Union are being held to a higher standard of scrutiny with the introduction of In Vitro Diagnostic Regulation (IVDR) 2017/746 by the European Commission (EC). \nOverview of In Vitro Diagnostic Regulation 2017/746 \nThe implementation of IVDR dramatically changes the regulatory landscape for IVD medical devices. Some of the biggest changes include an expanded definition of IVDs and a new classification of IVDs. Some other changes are the requirement of Unique Device Identification (UDI) on each device\, an expansion of the Quality Management System\, and the increased need for Notified Body (NB) review. \nThe transition into IVDR is already underway. Consequently\, IVDs marketed in the EU will continue to require a CE Marking certificate. This is necessary to verify that the device meets all the regulatory requirements. Indeed\, failure to meet the IVDR deadlines could be very costly to manufacturers. They would either lose their CE Marking or fail to obtain one. \nRead more on this topic in our blog post\, here.
URL:https://criterionedge.com/event/ivd-deep-dive-series-part-2-clinical-data-sources/
LOCATION:Webinar\, United States
CATEGORIES:IVDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/IVD-Deep-Dive-series-part-2-cover-033022.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20220309T110000
DTEND;TZID=America/Los_Angeles:20220309T114500
DTSTAMP:20220310T010736Z
CREATED:20220216T200043Z
LAST-MODIFIED:20220310T010736Z
UID:3337-1646823600-1646826300@criterionedge.com
SUMMARY:[Ask the Expert] Clinical Data for IVD
DESCRIPTION:Clinical Data for IVD: What is it and How Do I Find It?\nDo you have questions about how to generate\, collect\, analyze\, or assess clinical data pertaining to your IVD? What are the best practices for conducting literature searches? How do you effectively present your data in your performance evaluation report? Whether you are just beginning your PER preparations or are already in the process of writing\, we will provide insights and suggestions to help make the process of data collection\, extraction\, and presentation more streamlined. \nThis forum answers question like these and more. Click here to watch the recording. \nWho watch this forum?\n\n\nThose Regulatory\, Quality and Clinical leaders and teams who develop\, write\, review\, or approve performance evaluation reports for IVDR submissions.\n\n\nA Practical Guide: Conducting Systematic Literature Reviews in Support of IVDR Readiness\nThe implementation of IVDR requirements has challenged IVD manufacturers to align their internal processes and systems with these rigorous regulations. Therefore\, companies realize reviewing published literature for device-specific clinical data to establish the state-of-the-art (scientific validity) is imperative. In addition\, establishing clinical performance of their products is key. However\, many manufacturers may not be familiar with or have the capability to perform rigorous\, IVDR-compliant systematic literature reviews (SLR). Finally\, screening\, selection and data extraction are typically challenges for manufacturers as well. \nIn this presentation we break down the steps of the SLR process and take a wholistic approach to conducting an IVDR-compliant SLR. Next\, using case studies\, we illustrate the effective use of SLR-derived data to develop the Scientific Validity Report (SVR) and the Clinical Performance Report (CPR). \nKey Takeaways:\n\nReview the essential steps for conducting a robust\, methodologically-sound systematic literature review\nUsing a typical case study scenario\, learn how to effectively search\, identify\, screen\, review and extract critical published clinical data on your subject IVD device to support the development of the Scientific Validity and Clinical Performance Reports.\n\nWatch this webinar recording.
URL:https://criterionedge.com/event/ask-the-expert-clinical-data-for-ivd/
LOCATION:Virtual Q&A
CATEGORIES:IVDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/ask-the-expert-Clinical-Data-for-IVD-3.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20220302T110000
DTEND;TZID=America/Los_Angeles:20220302T120000
DTSTAMP:20220310T182318Z
CREATED:20220209T013909Z
LAST-MODIFIED:20220310T182318Z
UID:3272-1646218800-1646222400@criterionedge.com
SUMMARY:IVD Deep Dive Series Part 1
DESCRIPTION:Safety & Performance Objectives and Acceptance Criteria\nHow do I define acceptance criteria and how do I define safety and performance objectives?\nWhat are the biggest pitfalls or “Achille’s heels” to watch out for in identifying safety and performance measures? \nIn this webinar\, we’ll take a deep dive into the best practices to identify relevant and appropriate Safety and Performance Objectives and Acceptance Criteria for your Performance Evaluation Report (PER). First\, using a case study example\, we’ll discuss considerations and provide tips to help you select relevant Safety & Performance Objectives for your IVD. Additionally\, we’ll discuss how these objectives relate to the competitive landscape and State-of-the-Art (SOA) section of your PER. Then we’ll explain how these objectives help establish Acceptance Criteria\, a critical input for establishing the SOA in your PER. \nWatch the webinar recording. \nWho should watch this webinar?\nThose Regulatory\, Quality and Clinical leaders and teams who develop\, write\, review\, or approve performance evaluation reports for IVDR submissions. \n  \nKey Changes in the Regulatory Requirements for In Vitro Diagnostic Devices Marketed in the European Union Under IVDR 2017/746\nIn vitro diagnostic (IVD) medical devices in the European Union are being held to a higher standard of scrutiny with the introduction of In Vitro Diagnostic Regulation (IVDR) 2017/746 by the European Commission (EC). \nOverview of In Vitro Diagnostic Regulation 2017/746 \nThe implementation of IVDR dramatically changes the regulatory landscape for IVD medical devices. Some of the biggest changes include an expanded definition of IVDs and a new classification of IVDs. Some other changes are the requirement of Unique Device Identification (UDI) on each device\, an expansion of the Quality Management System\, and the increased need for Notified Body (NB) review. \nThe transition into IVDR is already underway. Consequently\, IVDs marketed in the EU will continue to require a CE Marking certificate. This is necessary to verify that the device meets all the regulatory requirements. Indeed\, failure to meet the IVDR deadlines could be very costly to manufacturers. They would either lose their CE Marking or fail to obtain one. \nRead more on this topic in our blog post\, here.
URL:https://criterionedge.com/event/ivd-deep-dive-series-part-1/
LOCATION:Webinar\, United States
CATEGORIES:IVDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/IVD-Deep-Dive-pt-1-cover-slide-030222.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20220223T110000
DTEND;TZID=America/Los_Angeles:20220223T120000
DTSTAMP:20220224T183558Z
CREATED:20220208T231550Z
LAST-MODIFIED:20220224T183558Z
UID:3300-1645614000-1645617600@criterionedge.com
SUMMARY:IVDR Essentials: Performance Evaluation Report - Early Planning and Preparation
DESCRIPTION:IVDR Essentials: Performance Evaluation Report – Early Planning and Preparation\n\nIn this webinar\, we discuss the importance of scoping to help you identify critical internal documents needed for IVDR-readiness. First\, we know a PER has many moving pieces. Accordingly\, we’ll present strategies to keep you and your team on track and help assess your own level of preparedness. Next\, using our CE Scoping checklist\, we will walk through the essential IVDR documents. Additionally\, we’ll discuss SOPs\, processes\, reports\, and templates\, and explain how each of these fits into the overall process of preparing to write. \nGoals for this webinar:\n\nEmphasize the importance of scoping\nDiscuss how to develop a checklist\nIllustrate how scoping may help you identify gaps or missing pieces that could lead to delays or challenges in your PER writing process\n\nWho should watch this webinar? \nThose Regulatory\, Quality and Clinical leaders and teams who are tasked with the development\, writing\, review or approval of performance evaluation reports for IVDR submissions. \nClick here to watch the recording of this webinar. \nLeveraging the MDR Experience for IVDR: Tips for Successful Performance Evaluation and PMS/PMCF Processes\nWatch our free webinar where Laurie Mitchell and Caroline Byrd discuss and share key “lessons learned” from their years of experience supporting medical device manufacturers in the transition from MDD to MDR and current IVD companies transition to IVDR compliance. How can the insights gained from the MDR experience support and inform IVD companies as they transition to IVDR? \nKey takeaways from the discussion include: \n\nEarly implementation of structural process change across the organization can empower future success with IVDR submissions to the notified bodies\nWhat are the key documents and processes essential for successful alignment with IVDR regulations\nThe importance of understanding the critical role of proactive and ongoing Systematic Literature Review search and screening activities\nUnexpected roadblocks\n\n\n\nWho should watch this webinar?\nAll regulatory\, clinical\, and scientific professionals who develop\, write\, review\, or approve scientific manuscripts\, reports\, presentations\, and other forms of communications in the medical device\, pharmaceutical\, and diagnostics space. \nWatch the recording.
URL:https://criterionedge.com/event/ivdr-essentials-performance-evaluation-report-early-planning-and-preparation/
LOCATION:Webinar\, United States
CATEGORIES:IVDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/IVDR-Essentials-cover-slide-022322.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20220209T110000
DTEND;TZID=America/Los_Angeles:20220209T114500
DTSTAMP:20220301T215212Z
CREATED:20220207T201845Z
LAST-MODIFIED:20220301T215212Z
UID:3292-1644404400-1644407100@criterionedge.com
SUMMARY:[Ask the Expert] Safety and Performance (MDR)
DESCRIPTION:This session’s topic: Safety and Performance Measures and Acceptance Criteria for MDR\nDo you have questions about how to identify meaningful safety and performance measures for the clinical evaluation? What are the best strategies for the verification of device safety and performance? Are you demonstrating that your safety and performance objectives are appropriate and clinically relevant​? Do you know how to specify acceptance criteria that are used to determine the acceptability of benefit-risk? \nThis is a 45-minute Q&A session during which President Laurie Mitchell will answer questions like these and more. Submit your questions when you register for this forum. Please be aware that answers will be limited to 3 minutes per questions. This forum will operate on a first come first serve basis. \nWho is this forum for?\nThose Regulatory\, Quality and Clinical leaders and teams who develop\, write\, review or approve Clinical Evaluation Reports for EU MDR submissions \nClick here to watch the recording. \nClearly Defining Measurable Safety and Performance Endpoints\nThe newest regulations for medical devices\, Medical Device Regulation (MDR) 2017/745 and MEDDEV 2.7/1 revision 4\, set high standards for confirming safety and performance according to the manufacturer’s Instructions for Use. Previously\, regulations under the old MDR and MEDDEV were not as demanding. Also\, manufacturers are not accustomed to the current systematic process of CER evaluations.   \nThese relatively new requirements for clinical evaluation extend to manufacturers sending new products into the European market. Additionally\, those that are already selling medical devices will have to follow these new requirements. Safety and performance are central components of the evidence-based evaluation process for obtaining and maintaining CE Marking for MDR 2017/745 and MEDDEV 2.7/1 rev 4. Consequently\, medical device manufacturers felt the pressure to comply by May 2021. \nRead more on this topic in our blog post\, here.
URL:https://criterionedge.com/event/ask-the-expert-safety-and-performance-4/
LOCATION:Virtual Q&A
CATEGORIES:MDR Webinars
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20220202T110000
DTEND;TZID=America/Los_Angeles:20220202T120000
DTSTAMP:20220202T232434Z
CREATED:20220113T190137Z
LAST-MODIFIED:20220202T232434Z
UID:3245-1643799600-1643803200@criterionedge.com
SUMMARY:How to Establish the State-of-the-Art Within the Scientific Validity Report
DESCRIPTION:How to Establish the State-of-the-Art Within the Scientific Validity Report\nIn this presentation\, Criterion Edge’s Principal Medical Writer\, Dr. Sarah Chavez\, will present focused strategies on building an IVDR-aligned State-of-the-Art (SOA) section within the Scientific Validity Report (SVR). She will also talk about the critical role of the SVR as it relates to the overall performance evaluation process. In addition\, you will learn how to assess your SVR project for unanticipated roadblocks and delays. Finally\, you’ll see how indecision or incomplete supporting documents can negatively impact SOA (and therefore\, SVR) quality and timelines.  \nKey Takeaways: \n\nThe foundational role of the SOA in the SVR \nThe required components of the SOA such as the safety and performance objectives \nThe importance of a robust systematic literature review (SLR) to support your SOA \n\nWho should watch the recording?\n\n\nThose Regulatory\, Quality and Clinical leaders\, regulatory writers\, and teams who are develop\, write\, review\, or approve of Performance Evaluation Reports for EU IVDR submission. Anyone interested in learning more about IVDR requirements for PERs is encouraged to attend as well. \nClick here to watch the recording of this webinar.\n\n\n\nA Practical Guide: Conducting Systematic Literature Reviews in Support of IVDR Readiness\n\n\nWith the implementation of IVDR requirements\, IVD manufacturers have been challenged to align their internal processes and systems to comply with these rigorous regulations. Companies realize the need to review published literature for device-specific clinical data to establish the state of the art (scientific validity) and clinical performance of their products\, however many manufacturers may not be familiar with or have the capability to perform rigorous\, IVDR-compliant systematic literature reviews (SLR)\, screening\, selection and data extraction. \nIn this practical presentation\, Criterion Edge breaks down the steps of the SLR process and takes a wholistic approach to conducting an IVDR-compliant SLR. Using case studies\, the presentation illustrates the effective use of SLR-derived data to develop the Scientific Validity Report (SVR) and the Clinical Performance Report (CPR). Watch this webinar.
URL:https://criterionedge.com/event/how-to-establish-the-state-of-the-art-within-the-scientific-validity-report/
LOCATION:Webinar\, United States
CATEGORIES:IVDR Webinars
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20220126T110000
DTEND;TZID=America/Los_Angeles:20220126T114500
DTSTAMP:20220301T215208Z
CREATED:20220106T185348Z
LAST-MODIFIED:20220301T215208Z
UID:3224-1643194800-1643197500@criterionedge.com
SUMMARY:[Ask the Expert] Safety & Performance (IVDR)
DESCRIPTION:This session’s topic: Safety and Performance Objectives and Acceptance Criteria for IVDR\nDo you have questions about how to establish meaningful safety and performance measures for the performance evaluation? What are the best methods and practices for identifying acceptance criteria? Are you demonstrating that your safety and performance objectives are appropriate and clinically relevant​? \nDuring this 45-minute Q&A session\, our experts answer commonly asked questions like these and more.  \nWho should watch the recording?\nThose Regulatory\, Quality and Clinical leaders and teams who develop\, write\, review or approve performance evaluation reports for IVDR submissions.  \nClick here to watch the recording of this webinar and get answers to commonly asked questions before the IVDR date of application. \nIVDR Compliance: Insights Gained from Writing MDR-Compliant CERs that Can Be Leveraged to Meet IVDR Requirements\n\n\nIn vitro diagnostic (IVD) medical device manufacturers are scrambling to meet the In Vitro Diagnostic Regulation (IVDR) 2017/746 requirements imposed by the European Union (EU). Changes in IVD classification require the majority of IVDs currently marketed in the EU to undergo notified body scrutiny under IVDR and obtain CE marking\, yet few guidance documents have been released. Lessons learned from meeting Medical Device Regulation (MDR) 2017/745 can help pave the way.  \nOne thing is clear\, if you have not yet started\, time is running out. The May 26\, 2022 Date of Application is a hard deadline. Applicable IVDs that are not certified under the IVDR by this deadline cannot be sold on the EU market.  Read our 5 tips to successfully meet the IVDR deadline here.
URL:https://criterionedge.com/event/ask-the-expert-safety-performance-objectives-acceptance-criteria-for-the-per/
LOCATION:Virtual Q&A
CATEGORIES:IVDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/ATE-SPO-and-AC-for-the-PER-cover-012622.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20220119T110000
DTEND;TZID=America/Los_Angeles:20220119T120000
DTSTAMP:20220120T044433Z
CREATED:20211211T004815Z
LAST-MODIFIED:20220120T044433Z
UID:3204-1642590000-1642593600@criterionedge.com
SUMMARY:Post-Market Literature Surveillance: Systematic Literature Review and Case Study
DESCRIPTION:Post-Market Literature Surveillance: Systematic Literature Review and Case Study Webinar\nJoining Criterion Edge’s President Laurie Mitchell\, is our guest speaker\, Queenita Fernandes\, Medtronic’s Medical Safety Manager\, Patient Monitoring & Respiratory Interventions​. In this webinar\, we will discuss how to deploy systematic literature review in order to augment post-market clinical surveillance\, and share our best tips on a robust systematic literature review process. Following this\, our guest speaker will share an informative case study illustrating more. \nWho should watch this webinar?\nThose Regulatory\, Quality and Clinical leaders and regulatory writers who are tasked with the development\, writing\, review or approval of Clinical Evaluation Reports for EU MDR submission\, or anyone interested in learning more about MDR requirements for CERs. \nClick here to watch the webinar recording. \nHow Can a Systematic Literature Review (SLR) Help Prevent Common Pitfalls in Meeting the Elementary Requirements of Clinical Evaluation for MEDDEV 2.7/1 revision 4 Clinical Evaluation Report (CER)?\nPerforming a methodologically sound literature review in the early stages of product development\, as well as in the later stages\, can help reduce most of the inadequacies highlighted by the European Commission in section A6 of MEDDEV 2.7/1 revision 4.  Section A6 provides examples of studies that lack scientific validity for the demonstration of adequate clinical performance and/or safety. \nHere are the seven areas highlighted in section A6 of MEDDEV 2.7/1 revision 4 that manufacturers tend to have the most problems in proving scientific validity: \n\nLack of information on elementary aspects\nNumbers too small for statistical significance\nImproper statistical methods\nLack of adequate controls\nImproper collection of mortality and serious adverse events data\nMisinterpretation by the authors\nIllegal activities\n\nRead more about the implications of these problems and how to improve in our blog post\, here.
URL:https://criterionedge.com/event/post-market-literature-surveillance-systematic-literature-review-and-case-study/
LOCATION:Webinar\, United States
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20211117T110000
DTEND;TZID=America/Los_Angeles:20211117T114500
DTSTAMP:20211118T002036Z
CREATED:20210813T035823Z
LAST-MODIFIED:20211118T002036Z
UID:2777-1637146800-1637149500@criterionedge.com
SUMMARY:[Ask the Expert] Safety and Performance
DESCRIPTION:This session’s topic: Safety and Performance Measures and Acceptance Criteria\nDo you have questions about how to identify meaningful safety and performance measures for the clinical evaluation? What are the best strategies for the verification of device safety and performance? Are you demonstrating that your safety and performance objectives are appropriate and clinically relevant​? Do you know how to specify acceptance criteria that are used to determine the acceptability of benefit-risk? \nDuring this presentation\, President Laurie Mitchell and Principal Medical Writer\, Dr. Sarah Chavez\, answer questions on how to identify meaningful safety and performance endpoints\, ensure they are appropriate and clinically relevant\, how to specify acceptance criteria ranges\, and more. \nWho should watch the recording?\nThose Regulatory\, Quality and Clinical leaders and teams who develop\, write\, review or approve Clinical Evaluation or Performance Evaluation Reports for EU MDR or IVDR submissions \nClick here to watch the recording! \nClearly Defining Measurable Safety and Performance Endpoints\nThe newest regulations for medical devices\, Medical Device Regulation (MDR) 2017/745 and MEDDEV 2.7/1 revision 4\, set high standards for confirming safety and performance according to the manufacturer’s Instructions for Use. Previously\, regulations under the old MDR and MEDDEV were not as demanding. Also\, manufacturers are not accustomed to the current systematic process of CER evaluations.   \nThese relatively new requirements for clinical evaluation extend to manufacturers sending new products into the European market. Additionally\, those that are already selling medical devices will have to follow these new requirements. Safety and performance are central components of the evidence-based evaluation process for obtaining and maintaining CE Marking for MDR 2017/745 and MEDDEV 2.7/1 rev 4. Consequently\, medical device manufacturers felt the pressure to comply by May 2021. \nRead more on this topic in our blog post\, here.
URL:https://criterionedge.com/event/ask-the-expert-safety-and-performance-2/
LOCATION:Virtual Q&A
CATEGORIES:IVDR Webinars,MDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/ask-the-expert-cover-slide-safety-and-performance-11-17-21.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20211103T110000
DTEND;TZID=America/Los_Angeles:20211103T114500
DTSTAMP:20211104T202232Z
CREATED:20210813T035040Z
LAST-MODIFIED:20211104T202232Z
UID:2768-1635937200-1635939900@criterionedge.com
SUMMARY:[Ask the Expert] The Importance of Clinical Data
DESCRIPTION:The Importance of Clinical Data: Sources of Data\, Literature Searches\, Weighting & Appraisal and Effective Presentation in your CER or PER\nDo you have questions about how to generate\, collect\, analyze\, and assess clinical data pertaining to your IVD or medical device? And what are the best practices for conducting literature searches? How do you effectively present your data in your clinical evaluation report or performance evaluation report? \nDuring this 45-minute Q&A session\, our President Laurie Mitchell is joined by Dr. Sarah Chavez  to answer some commonly asked questions and give expert advice. Answers cover how to best collect and present data on similar (competitor) devices as well as data collection strategies for new products. In addition\, there is discussion around best practices for and examples of appraising literature and clinical data. Also\, clarification between safety & performance metrics and risks & benefits analyses is given\, plus so much more. \nWatch the recording! \nWho should watch this forum?\nThose Regulatory\, Quality and Clinical leaders and teams who develop\, write\, review or approve clinical evaluation reports or performance evaluation reports for EU MDR or IVDR submissions. \nHow to Empower Data-Driven Decisions in Your Organization\nEvery day\, pharma and medical device companies need data from Systematic Literature Reviews (SLRs) to inform\, direct\, and help drive their internal processes and decisions. Of course\, to comply with global regulatory requirements\, clinical literature is also required. Conducting SLRs to search\, screen\, and extract data from published sources can present challenges to your team in terms of expertise (e.g.\, medical librarian)\, methodology\, and resources. It takes trained people with the availability to screen\, review\, and analyze the literature. \nDownload our free white paper\, Systematic Literature Review: How to Empower Data-Driven Decisions in Your Organization to read more on this topic. \nYou can also watch our webinar on this topic. \nOur President Laurie Mitchell joins Jennifer Tetzlaff\, Research Product Specialist with Evidence Partners\, to talk to you about the following points: \n\nExamples of how the use of published data can support regulatory expectations\nWhen to conduct a systematic literature review\nBest practices for conducting a methodologically-sound SLR\nUse of available tools and technology
URL:https://criterionedge.com/event/ask-the-expert-the-importance-of-clinical-data-2/
LOCATION:Virtual Q&A
CATEGORIES:IVDR Webinars,MDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/SP-Measures-final-cover-with-date-11.17.21.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20211020T110000
DTEND;TZID=America/Los_Angeles:20211020T114500
DTSTAMP:20211021T213152Z
CREATED:20210813T032002Z
LAST-MODIFIED:20211021T213152Z
UID:2765-1634727600-1634730300@criterionedge.com
SUMMARY:[Ask the Expert] Performance Evaluation Report
DESCRIPTION:This session’s topic: The Performance Evaluation Report (PER)\nWith the implementation of IVDR requirements\, IVD manufacturers have been challenged to align their internal processes and systems to comply with these rigorous regulations. What challenges are you or your team currently facing? Which areas do you need performance evaluation report guidance? \nDuring this 45-minute Q&A session\, our President Laurie Mitchell and Principal Medical Writer Dr. Sarah Chavez answered questions on the role of the State-of-the-Art section within the PER\, whether using a PER template is right for you including what the notified body expects to see\, and the methodology and strategy for PER\, PEP\, and PMPF plans. \nWho should watch this webinar?\nRegulatory\, Quality and Clinical leaders and teams who develop\, write\, review or approve Performance Evaluation Reports for EU IVDR submission. \nWatch the recording! \nWhat You Need to Be Compliant\nWatch our recent webinar for more performance evaluation report guidance. We provide an overview of the State of the Art section\, and explain how it fits into the overall process of writing a successful\, IVDR-compliant PER. Additionally\, we discuss the importance of readiness assessments and gap analyses. Then we help you identify critical resources\, feeder documents\, and expertise needed to consider your IVD “state-of-the-art.” Ultimately\, knowing what the Notified Body expects to see will help you avoid project delays and discover efficiencies in the SOA development process. \nUltimately\, the In Vitro Diagnostic Device Regulation 2017/746 is making sweeping changes to the EU regulatory requirements for IVD devices. Read our blog post for more on this topic. In it\, we introduce some of the major requirements and list some of the important considerations for IVDR 2017/746 compliance.
URL:https://criterionedge.com/event/ask-the-expert-performance-evaluation-report-2/
LOCATION:Virtual Q&A
CATEGORIES:IVDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/ask-the-expert-PER-102021.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20211006T110000
DTEND;TZID=America/Los_Angeles:20211006T114500
DTSTAMP:20211021T213522Z
CREATED:20210813T031751Z
LAST-MODIFIED:20211021T213522Z
UID:2762-1633518000-1633520700@criterionedge.com
SUMMARY:[Ask the Expert] Performance Evaluation Report
DESCRIPTION:This session’s topic: The Performance Evaluation Report (PER)\nWith the implementation of IVDR requirements\, IVD manufacturers have been challenged to align their internal processes and systems to comply with these rigorous regulations. What challenges are you or your team currently facing? Which areas do you need performance evaluation report guidance? \nDuring this 45-minute Q&A session\, our President Laurie Mitchell and Principal Medical Writer Dr. Sarah Chavez answered questions on the biggest pitfalls to look out for when writing a PER. In addition\, they discuss how to align your internal processes and systems to comply with rigorous IVDR regulations and what technical documents are required for the PER\, PEP\, and PMPF. \nWho should watch this webinar?\nRegulatory\, Quality and Clinical leaders and teams who develop\, write\, review or approve Performance Evaluation Reports for EU IVDR submission. \nWatch the recording! \nWhat You Need to Be Compliant\nWatch our recent webinar for more performance evaluation report guidance. We provide an overview of the State of the Art section\, and explain how it fits into the overall process of writing a successful\, IVDR-compliant PER. Additionally\, we discuss the importance of readiness assessments and gap analyses. Then we help you identify critical resources\, feeder documents\, and expertise needed to consider your IVD “state-of-the-art.” Ultimately\, knowing what the Notified Body expects to see will help you avoid project delays and discover efficiencies in the SOA development process. \nUltimately\, the In Vitro Diagnostic Device Regulation 2017/746 is making sweeping changes to the EU regulatory requirements for IVD devices. Read our blog post for more on this topic. In it\, we introduce some of the major requirements and list some of the important considerations for IVDR 2017/746 compliance.
URL:https://criterionedge.com/event/ask-the-expert-performance-evaluation-report/
LOCATION:Virtual Q&A
CATEGORIES:IVDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/ask-the-expert-PER-100621.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20210922T100000
DTEND;TZID=America/Los_Angeles:20210922T104500
DTSTAMP:20211021T214556Z
CREATED:20210813T023130Z
LAST-MODIFIED:20211021T214556Z
UID:2758-1632304800-1632307500@criterionedge.com
SUMMARY:[Ask the Expert] Safety and Performance
DESCRIPTION:This session’s topic: Safety and Performance Measures and Acceptance Criteria\nDo you have questions about how to identify meaningful safety and performance measures for the clinical evaluation? What are the best strategies for the verification of device safety and performance? \nDuring this 45-minute Q&A session\, our President Laurie Mitchell answers questions on how to identify meaningful safety and performance endpoints. In addition she discusses how to demonstrate that S&P endpoints are appropriate and clinically relevant​\, as well as how to specify acceptance criteria to determine the acceptability of benefit-risk. \nWho should watch this webinar?\nThose Regulatory\, Quality and Clinical leaders and teams who develop\, write\, review or approve Clinical Evaluation Reports for EU MDR or IVDR submissions \nWatch the recording! \nClearly Defining Measurable Safety and Performance Endpoints\nThe newest regulations for medical devices\, Medical Device Regulation (MDR) 2017/745 and MEDDEV 2.7/1 revision 4\, set high standards for confirming safety and performance according to the manufacturer’s Instructions for Use. Previously\, regulations under the old MDR and MEDDEV were not as demanding. Also\, manufacturers are not accustomed to the current systematic process of CER evaluations.   \nThese relatively new requirements for clinical evaluation extend to manufacturers sending new products into the European market. Additionally\, those that are already selling medical devices will have to follow these new requirements. Safety and performance are central components of the evidence-based evaluation process for obtaining and maintaining CE Marking for MDR 2017/745 and MEDDEV 2.7/1 rev 4. Consequently\, medical device manufacturers felt the pressure to comply by May 2021. \nRead more on this topic in our blog post\, here.
URL:https://criterionedge.com/event/ask-the-expert-safety-and-performance/
LOCATION:Virtual Q&A
CATEGORIES:IVDR Webinars,MDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/ask-the-expert-s-p-measures-092221.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20210915T110000
DTEND;TZID=America/Los_Angeles:20210915T120000
DTSTAMP:20211021T214832Z
CREATED:20210729T221916Z
LAST-MODIFIED:20211021T214832Z
UID:2507-1631703600-1631707200@criterionedge.com
SUMMARY:How to Establish the Competitive Landscape Within the Scientific Validity Report
DESCRIPTION:In this practical presentation\, Dr. Sarah Chavez\, presents a detailed outline of the State-of-the-Art search within the Performance Evaluation Report (PER). Additionally\, she will distinguish between the purpose and scope of the state-of-the-art and the Competitor search. For example\, the SLR approach\, data screening\, and data presentation will be addressed. \nYou will learn:\n\nThe importance of the SOA SLR for providing background and general information\nHow to establish acceptance criteria with data\nHow to assess the safety and performance of your IVD with a systematic approach to the Competitor SLR process\n\nWho should watch the recording?\nThose Regulatory\, Quality and Clinical leaders and teams who develop\, write\, review or approve Performance Evaluation Reports for EU IVDR submission. Also\, anyone interested in learning more about the competitive landscape within the Scientific Validity Report should attend. \nWatch the recording! \nBuilding a Solid Foundation for your PER to Support IVDR Readiness\nWatch our recent webinar where we present an overview of the State of the Art section. Namely\, we explain how it fits into the overall process of writing a successful\, IVDR-compliant Performance Evaluation Report (PER). In addition\, a complete readiness assessment and gap analysis will help you identify critical resources\, feeder documents\, and expertise needed establish your IVD as “state-of-the-art.” Ultimately\, knowing what the Notified Body expects to see will help you avoid project delays and discover efficiencies in the SOA development process. \nYou will learn: \n\nThe importance of planning and preparation before you even begin to write the SOA\nThe complete outline of the SOA literature review and assessment process to understand “documentation” needs and what the Notified Body may be expecting to see as part of the Scientific Validity Report (SVR)\nThe potential impact  of incorrect/incomplete documents or processes\n\nTo watch the free webinar recording\, State of the Art: Building a Solid Foundation for your PER to Support IVDR Readiness\, click here.
URL:https://criterionedge.com/event/how-to-establish-the-competitive-landscape-within-the-scientific-validity-report/
LOCATION:Webinar\, United States
CATEGORIES:IVDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/competitive-landscape-cover-with-date.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20210902T110000
DTEND;TZID=America/Los_Angeles:20210902T114500
DTSTAMP:20211021T215036Z
CREATED:20210901T232210Z
LAST-MODIFIED:20211021T215036Z
UID:2846-1630580400-1630583100@criterionedge.com
SUMMARY:[Ask the Expert] Measurable Objectives and Acceptance Criteria
DESCRIPTION:This session’s topic: Clinical Evaluation: Measurable Objectives and Acceptance Criteria to Verify Device Safety and Performance\nAre you looking for strategies for the verification of device safety and performance in the clinical evaluation? Are you struggling to define device safety and performance objectives? During this 45-minute Q&A session\, our President Laurie Mitchell answers questions regarding how to identify meaningful safety and performance endpoints. In addition\, she discusses how to demonstrate safety and performance objectives are appropriate and clinically relevant as well as what acceptance criteria is and how to define it. \nWho should watch this webinar?\nThose Regulatory\, Quality and Clinical leaders and regulatory writers who are tasked with the development\, writing\, review or approval of Clinical Evaluation Reports for EU MDR submission\, or anyone interested in learning more about MDR requirements for CERs. If you attended our hour-long webinar on August 25\, but we did not answer your questions we encourage you to attend to get your questions answered on this topic. \nWatch the recording! \nClearly Defining Measurable Safety and Performance Endpoints\nAll medical devices selling in Europe must have a Clinical Evaluation Report (CER). Specific and measurable safety and performance endpoints are paramount for an acceptable CER. However\, many small medical device manufacturers are struggling to adequately define and subsequently document measurable safety and performance endpoints\, especially in the literature review\, to support an evidence-based evaluation.  \nThe newest regulations for medical devices\, Medical Device Regulation (MDR) 2017/745 and MEDDEV 2.7/1 revision 4\, set high standards for confirming safety and performance according to the manufacturer’s Instructions for Use. Previously\, regulations under the old MDR and MEDDEV were not as demanding. Also\, manufacturers are not accustomed to the current systematic process of CER evaluations.  \nRead more on this topic in our recent blog post\, Clearly Defining Measurable Safety and Performance Endpoints in Clinical Evaluation Reports (CER) is a Real Challenge for Medical Device Manufacturers.
URL:https://criterionedge.com/event/ask-the-expert-measurable-objectives-and-acceptance-criteria/
LOCATION:Virtual Q&A
CATEGORIES:MDR Webinars
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20210901T110000
DTEND;TZID=America/Los_Angeles:20210901T114500
DTSTAMP:20220324T235804Z
CREATED:20210811T195140Z
LAST-MODIFIED:20220324T235804Z
UID:2722-1630494000-1630496700@criterionedge.com
SUMMARY:[Ask the Expert] Systematic Literature Review
DESCRIPTION:This session’s topic: Systematic Literature Review: What is it and why is it so important?\nDo you have specific questions about the steps of the systematic literature review process or questions regarding your medical device or IVD? During this 45-minute Q&A session\, our President Laurie Mitchell answers questions about the steps to conduct a methodologically sound SLR​​. In addition\, she discusses how to leverage published data to meet regulatory expectations and inform internal decision-making from marketing initiatives and clinical strategies to global regulatory requirements. \nWho should watch this webinar?\nThose Regulatory\, Quality and Clinical leaders and teams who develop\, write\, review or approve Systematic Literature Reviews for EU MDR or IVDR submissions\, meta-analyses\, regulatory response support\, development of clinical marketing materials\, etc. \nWatch the recording! \nWatch Our Related Webinar for an In-Depth Look at the SLR Process\nWith the implementation of IVDR and MDR requirements\, device manufacturers often struggle to align their internal processes and systems to comply with these rigorous regulations. Consequently\, companies realize the need to review published literature for device-specific clinical data. However many manufacturers may not be familiar with or have the capability to perform all steps of the rigorous systematic literature review process\, including screening\, selection and data extraction.  \nWatch our webinar where we break down the steps of the SLR process and take a wholistic approach to conducting an IVDR-compliant SLR. Using case studies\, the presentation illustrates the effective use of SLR-derived data to develop the Scientific Validity Report (SVR) and the Clinical Performance Report (CPR). We encourage professionals from the medical device industry to watch as well\, as the content is also relevant to MDR requirements\, which align closely with IVDR.
URL:https://criterionedge.com/event/systematic-literature-review-what-is-it-and-why-is-it-so-important/
LOCATION:Virtual Q&A
CATEGORIES:IVDR Webinars,MDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/ask-the-expert-SLR-090121.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20210826T110000
DTEND;TZID=America/Los_Angeles:20210826T113000
DTSTAMP:20211021T215555Z
CREATED:20210813T011516Z
LAST-MODIFIED:20211021T215555Z
UID:2740-1629975600-1629977400@criterionedge.com
SUMMARY:[Ask the Expert] The Importance of Clinical Data
DESCRIPTION:This session’s topic: The Importance of Clinical Data: Sources of Data\, Literature Searches\, Weighting & Appraisal and Effective Presentation in your CER or PER\nDuring this 30 minute Q&A session\, our President Laurie Mitchell answers questions on how to generate\, analyze\, and assess clinical data pertaining to your IVD or medical device. In addition\, she discusses the best practices for conducting literature searches and how to effectively present your data in your Clinical Evaluation Report or Performance Evaluation Report. \nWho should watch this webinar?\nThose Regulatory\, Quality and Clinical leaders and teams who develop\, write\, review or approve clinical evaluation reports or performance evaluation reports for EU MDR or IVDR submissions. \nWatch the recording! \nHow to Empower Data-Driven Decisions in Your Organization\nEvery day\, pharma and medical device companies need data from Systematic Literature Reviews (SLRs) to inform\, direct\, and help drive their internal processes and decisions. Of course\, clinical literature is also required for compliance with global regulatory requirements. Conducting SLRs to search\, screen\, and extract data from published sources can present challenges to your team in terms of expertise (e.g.\, medical librarian)\, methodology\, and resources. It takes trained people with the availability to screen\, review\, and analyze the literature. \nDownload our free white paper\, Systematic Literature Review: How to Empower Data-Driven Decisions in Your Organization to read more on this topic. \nYou can also watch our webinar on this topic. \nOur President Laurie Mitchell joins Jennifer Tetzlaff\, Research Product Specialist with Evidence Partners\, to talk to you about the following points: \n\nExamples of how the use of published data can support regulatory expectations\nWhen to conduct a systematic literature review\nBest practices for conducting a methodologically-sound SLR\nUse of available tools and technology
URL:https://criterionedge.com/event/ask-the-expert-the-importance-of-clinical-data/
LOCATION:Virtual Q&A
CATEGORIES:IVDR Webinars,MDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/ask-the-expert-clinical-data-082621.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
END:VCALENDAR