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DTSTART;TZID=America/Chicago:20250409T120000
DTEND;TZID=America/Chicago:20250409T130000
DTSTAMP:20260613T094559Z
CREATED:20250320T203944Z
LAST-MODIFIED:20260613T094559Z
UID:6697-1744200000-1744203600@criterionedge.com
SUMMARY:Maximizing the Value of Literature Reviews for IVD\, From Competitive Intelligence to Market Success
DESCRIPTION:A well-executed systematic literature review (SLR) is more than just a regulatory compliance requirement—it’s a strategic asset for your entire organization. In this webinar\, we’ll explore how a well-designed systematic literature review can support regulatory submissions\, enhance competitive intelligence\, and facilitate post-market surveillance while saving time\, money\, and resources. Using real-world examples\, our experts will share best practices for designing an effective SLR that meets FDA and IVDR requirements and serves as a valuable tool for R&D\, regulatory\, and marketing teams.  \nLearning Objectives:  \n\nUncover the Hidden Advantages of SLRs: Learn why a methodologically sound systematic literature review (SLR) outperforms traditional internet searches—and how it provides more credible\, comprehensive\, and actionable insights. \n\n\nMaster the Art of Search Strategy: Discover expert techniques for selecting the right keywords\, refining search criteria\, and optimizing data collection to ensure your SLR is both thorough and highly relevant to regulatory and business needs. \n\n\nTurn Published Data into a Strategic Asset Across the Organization: Explore how leveraging existing literature not only meets FDA and IVDR expectations but also informs internal decision-making across teams\, competitive positioning\, and risk assessment. \n\n\nSee the Impact in Action: Through the examination of real-world scenarios\, you will gain a deeper understanding of how different teams—from R&D and regulatory affairs to marketing—can extract value from a well-executed SLR to drive smarter business and compliance strategies. \n\nWATCH NOW
URL:https://criterionedge.com/event/maximizing-the-value-of-literature-reviews-for-ivd-from-competitive-intelligence-to-market-success/
LOCATION:Webinar\, United States
CATEGORIES:IVDR Webinars
ATTACH;FMTTYPE=image/webp:https://criterionedge.com/wp-content/uploads/ybwyseimrudigy1ria6s.webp
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Chicago:20250305T120000
DTEND;TZID=America/Chicago:20250305T130000
DTSTAMP:20250306T175847Z
CREATED:20250218T235731Z
LAST-MODIFIED:20250306T175847Z
UID:6639-1741176000-1741179600@criterionedge.com
SUMMARY:The Current State of Medical Device Regulations: Strategies to Support a Successful Technical Documentation Assessment (TDA)
DESCRIPTION:Here we are\, nearly eight years after the publication of the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) and Medical Devices Regulation (EU) 2017/745 (MDR). As the May 2025 deadlines loom\, many manufacturers are facing the reality of what implementing these regulations actually entails. While the manufacturers seem to have been given more time\, a lack of clarity about clinical evidence expectations has left many companies struggling.   \nIn spite of these extended deadlines\, manufacturers continue to face challenges in implementing these regulations. Key pain points include:  \n\nEscalating costs of obtaining and maintaining certifications\, leading to budget uncertainty\nChallenges finding qualified regulatory affairs professionals and technical writers\nLack of clarity regarding clinical evidence requirements\nUnclear expectations from IVD and medical device Notified Bodies \n\nIn this webinar\, we will discuss strategies to support your Regulatory Affairs team as they strive to meet the requirements for technical documentation\, drawing from our experience with clinical evidence expectations for the Performance/Clinical Evaluation Reports (PERs/CERs) and Post Market Surveillance Reports for a wide range of medical devices and IVDs.  \nLearning objectives:   \n\nDiscuss common challenges (and deficiencies) identified during the Notified Body review of the PER/CER and PMS reports.\nExplain how Technical Documentation Assessments (TDA) can affect your timeline for certification.\nProvide real-world examples to illustrate the cost-effectiveness of preparing and planning for these extensive requirements early in your product’s lifecycle.\nDescribe our approach to meeting clinical evidence expectations through well-defined research questions\, targeted systematic literature reviews\, and well-organized templates.\n \n\nWATCH NOW
URL:https://criterionedge.com/event/the-current-state-of-medical-device-regulations-strategies-to-support-a-successful-technical-documentation-assessment-tda/
LOCATION:Webinar\, United States
CATEGORIES:IVDR Webinars,MDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/Webinar-Graphic-Mar-5th-2025-v1.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Chicago:20250129T120000
DTEND;TZID=America/Chicago:20250129T130000
DTSTAMP:20250116T160305Z
CREATED:20250109T213710Z
LAST-MODIFIED:20250116T160305Z
UID:6632-1738152000-1738155600@criterionedge.com
SUMMARY:FDA Pre-Determined Change Control Plan (PCCP): Recommendations for Planning Your Strategy and Approach
DESCRIPTION:Overview\nUnderstand the intricacies of the FDA’s Pre-Determined Change Control Plan (PCCP) and its application across medical devices and in vitro diagnostics (IVDs). This webinar is designed for global regulatory and quality professionals aiming to streamline their strategies for managing post-market device modifications. Attendees will walk away with a deeper understanding of regulatory changes and actionable steps to support compliance objectives and improve efficiency in submissions. \nLearning Objectives:\n\nUnderstand the FDA’s PCCP framework\, how it relates to iterative improvements in software\, and its applications for medical devices and IVDs.\nLearn how to prepare effective PCCP submissions with considerations for risk management and post market surveillance documentation.\nExplore strategies for integrating PCCPs into regulatory and product lifecycle planning.\nIdentify and address challenges in PCCP implementation.\nGain practical insights from real-world examples and FDA guidance.\n\nReserve Your Spot
URL:https://criterionedge.com/event/fda-pre-determined-change-control-plan-pccp-recommendations-for-planning-your-strategy-and-approach/
LOCATION:Webinar\, United States
CATEGORIES:IVDR Webinars,MDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/Webinar-Graphic-Jan-29th-2025.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Chicago:20241113T120000
DTEND;TZID=America/Chicago:20241113T130000
DTSTAMP:20241114T185315Z
CREATED:20241022T151807Z
LAST-MODIFIED:20241114T185315Z
UID:6557-1731499200-1731502800@criterionedge.com
SUMMARY:Devices in Focus: How to Save Time & Money with Real World Evidence (RWE)
DESCRIPTION:Real world evidence is increasingly important for companies seeking to demonstrate device performance without the time and expense of extensive clinical trials. This webinar will explore how to effectively use real-world evidence in regulatory submissions to accelerate product approvals and meet post-market surveillance requirements. \nLearning Objectives: \n\nSummarize recent regulatory guidance pertaining to the use of RWE in regulatory submissions.\nDiscuss why RWE is valuable for your regulatory strategies from both a cost and time savings perspective.\nExplain potential challenges (and solutions) when using RWE to support safety and performance of your device.\nIdentify strategies for integrating RWE into regulatory submissions using case studies and recent examples encountered by our Criterion Edge team.\n\nWho is this for: \n\nRegulatory Affairs\nChief Medical Officers\nMedical & Scientific Writers\n\n  \nWATCH NOW
URL:https://criterionedge.com/event/devices-in-focus-how-to-save-time-money-with-real-world-evidence-rwe/
LOCATION:Webinar\, United States
CATEGORIES:IVDR Webinars,MDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/Nov-14th-2024-Sarah-Chavez.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Chicago:20240925T120000
DTEND;TZID=America/Chicago:20240925T130000
DTSTAMP:20240927T211511Z
CREATED:20240904T195155Z
LAST-MODIFIED:20240927T211511Z
UID:6520-1727265600-1727269200@criterionedge.com
SUMMARY:Good Science vs. Bad Writing: Strategies for Building an Effective Scientific Writing Team
DESCRIPTION:Writing is not an innate talent\, but a learned skill requiring extensive training and practice. Scientific writing is no exception.  As scientists\, we have all seen examples of how bad writing and ineffective communication can detract from good science. The goal of this presentation is to describe strategies to support effective partnerships between regulatory experts and your writing team. \nIn this presentation\, we will discuss what it takes to produce a document that is clear\, concise\, and complete\, meeting basic regulatory requirements but also effectively telling the story of your device.  We will also present strategies to help you assess your current writing processes and offer tips for document preparation to support effective writing partnerships within your organization. And finally\, we will describe recent themes and feedback regarding medical device and in vitro device evaluation reports\, as well as ways to proactively design solutions to common concerns including time\, budget\, bandwidth\, and internal resources. \nDuring this presentation\, we will… \n\nDiscuss how to plan a realistic timeline for your project.\nProvide advice for assessing your team’s bandwidth and scientific writing expertise.\nPresent examples of key documents and inputs needed early in the writing process.\nDescribe how Regulatory Affairs can support critical decision-making throughout the planning and preparation of these key reports.\nProvide practical strategies to support successful completion of these writing projects with an outside writing partner.\n\n\nWATCH NOW
URL:https://criterionedge.com/event/good-science-vs-bad-writing-strategies-for-building-an-effective-scientific-writing-team/
LOCATION:Webinar\, United States
CATEGORIES:IVDR Webinars,MDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/Webinar-Cover-25-Sep-2024-v4.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Chicago:20240625T130000
DTEND;TZID=America/Chicago:20240625T140000
DTSTAMP:20240815T202621Z
CREATED:20240606T151732Z
LAST-MODIFIED:20240815T202621Z
UID:5546-1719320400-1719324000@criterionedge.com
SUMMARY:Considerations for Companion Diagnostics: Lessons Learned and Key Takeaways from DIA 2024
DESCRIPTION:The In Vitro Diagnostics Regulation (IVDR) took effect in May 2022 and has introduced substantial changes in the regulatory framework for in vitro diagnostic medical devices (IVDs) in Europe. IVD manufacturers are expected to meet more rigorous standards for clinical evidence\, with up to 80% of IVDs requiring Notified Body certificates under IVDR. \nDr. Sarah Chavez\, Criterion Edge Director of IVD Writing Services\, will discuss key insider insights gleaned from the 2024 DIA meeting to share and discuss the key take-aways from the Symposium\, including clinical evidence requirements and strategies to keep your report writing and data collection on track. \nJoin us for this webinar to discuss differences in EU and US regulations for IVD clinical performance studies and potential implications for companion diagnostic developers. The goals of this webinar are to: \n\nUnderstand how new regulatory requirements apply to CDx and what are potential implications from both the IVD and Pharma partners’ perspectives.\nDevelop a strategic approach to ensure compliance with IVDR requirements for CDx\, covering essential aspects such as quality management\, documentation\, and early interactions with your notified body.\nAddress common challenges faced during the implementation of IVDR requirements for CDx\, exploring potential solutions and proactive measures to streamline the regulatory compliance process.\n\nWATCH NOW
URL:https://criterionedge.com/event/considerations-for-companion-diagnostics-lessons-learned-and-key-takeaways-from-dia-2024/
LOCATION:Webinar\, United States
CATEGORIES:IVDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/June-25-2024.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Chicago:20240522T130000
DTEND;TZID=America/Chicago:20240522T140000
DTSTAMP:20240815T202821Z
CREATED:20240502T193435Z
LAST-MODIFIED:20240815T202821Z
UID:4841-1716382800-1716386400@criterionedge.com
SUMMARY:IVDR in Focus: Tips for Performance Evaluation Planning to Support Your Transition from IVDD to IVDR
DESCRIPTION:While the concept of a “performance evaluation” hasn’t changed much over the past two decades\, IVDR requirements regarding the amount and extent of technical documentation have significantly changed compared to the IVDD. Annex XIII of the IVDR specifies the contents of two new documents: the performance evaluation plan (PEP) and the performance evaluation report (PER). \nTo help manufacturers prepare and comply with the IVDR\, we have compiled some tips for developing and implementing a successful PEP as you prepare for your IVDR submissions. \nLearning Objectives: \n\nDescribe the scope and objectives of the PEP\, including considerations to identify the clinical claims\, the target population\, the clinical conditions\, the comparators\, and the endpoints.\nReview how to conduct a comprehensive systematic literature review\, a critical component of the PEP which provides the basis for the clinical evidence\, both favorable and unfavorable.\nDiscuss strategies to prepare a detailed scientific validity report (SVR)\, a new requirement under the IVDR to provide a clear rationale and scientific justification for the choice of the analyte or marker\, as well as the evidence of its association with the clinical condition or physiological state.\nDefine the requirements of the analytical performance report (APR)\, another new requirement under the IVDR which seeks to demonstrate the analytical performance of the IVD in terms of its ability to correctly measure the analyte or marker.\nClarify the expectations for sufficient clinical data contained within the clinical performance report (CPR)\, a key requirement under the IVDR that demonstrates the clinical performance of the IVD in terms of its ability to correctly identify or predict the clinical condition or physiological state of the target population\n\nWho is this webinar for?\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. \n  \nWATCH NOW
URL:https://criterionedge.com/event/ivdr-in-focus-tips-for-performance-evaluation-planning-to-support-your-transition-from-ivdd-to-ivdr-2/
LOCATION:Webinar\, United States
CATEGORIES:IVDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/May-22-2024.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20230308T110000
DTEND;TZID=America/Los_Angeles:20230308T120000
DTSTAMP:20230228T221554Z
CREATED:20230228T221554Z
LAST-MODIFIED:20230228T221554Z
UID:4835-1678273200-1678276800@criterionedge.com
SUMMARY:Stay Focused: The Purpose of the SVR and Tips for Building a Strong PER Foundation
DESCRIPTION:The goal of performance evaluation is to show that your IVD performs as intended and meets the acceptance criteria\, therefore establishing that your IVD may be considered state of the art. Remember: the PER is a product\, but it is documenting a process. Performance evaluation can be straightforward if your analyte has a well-established association with a clinical condition. But what is the purpose of the SVR\, and how should you approach it when there is too much or not enough data? \nThis webinar will discuss the role of data sufficiency\, the importance of developing a solid strategy to establish scientific validity\, how gaps in the SVR can significantly impact the quality of the PER\, and how proper scoping can help maximize success when it comes to a performance evaluation. \nIn this webinar\, you will learn\n1. How to clearly define what information should (and shouldn’t) be presented within the Scientific Validity Report.\n2. How the systematic literature review process supports and connects the SVR\, CPR\, and APR by leveraging published data.\n3. How to conduct gap assessments to assess IVDR readiness and develop strategies to increase efficiencies in the performance evaluation process to support the SVR. \nAt the end of the presentation\, we will dedicate 15 minutes to answering your questions. Please submit your questions beforehand if you have any to help us prepare. Also\, you can submit your questions at any point during the presentation. \nWho should register for this webinar?\n\n\nThose Regulatory\, Quality and Clinical leaders and teams who develop\, write\, review or approve performance evaluation reports for IVDR submissions.\n\n\n\n\n\nClick here to watch the recording of this webinar. \nNew Requirements for In Vitro Diagnostics: Lessons Learned from the AAMI/FDA/BSI Annual Conference\nIn October 2022\, the AAMI/FDA/BSI Annual Conference discussed current knowledge and practical strategies to meet new IVDR clinical evidence requirements. Dr. Sarah Chavez\, Criterion Edge Director of IVD Writing Services\, was invited to speak with other regulatory\, notified body and industry leaders as panelists at the pre-conference workshop “New Requirements for In Vitro Diagnostics”. \nWatch Dr. Chavez’s recent webinar and benefit from key insider insights gleaned from this meeting. Sarah shares and discusses the key take-aways from the Symposium\, including clinical evidence requirements and strategies to keep your report writing and data collection on track.  Many companies are in the early stages of planning for IVDR\, so take a step towards IVDR readiness with these helpful suggestions for planning and preparation from the perspective of experienced regulatory writers. \nWatch the webinar recording here.
URL:https://criterionedge.com/event/stay-focused-the-purpose-of-the-svr-and-tips-for-building-a-strong-per-foundation-3/
LOCATION:Webinar\, United States
CATEGORIES:IVDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/Stay-Focused-The-Purpose-of-the-SVR-03.08.23.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20230201T110000
DTEND;TZID=America/Los_Angeles:20230201T120000
DTSTAMP:20230209T185651Z
CREATED:20230113T200731Z
LAST-MODIFIED:20230209T185651Z
UID:4105-1675249200-1675252800@criterionedge.com
SUMMARY:New Requirements for In Vitro Diagnostics: Lessons Learned from the AAMI/FDA/BSI Annual Conference
DESCRIPTION:New Requirements for In Vitro Diagnostics: Lessons Learned from the AAMI/FDA/BSI Annual Conference\nThe In Vitro Diagnostics Regulation (IVDR) took effect in May 2022 and has introduced substantial changes in the regulatory framework for in vitro diagnostic medical devices (IVDs) in Europe. IVD manufacturers are expected to meet more rigorous standards for clinical evidence\, with up to 80% of IVDs requiring Notified Body certificates under IVDR. \nIn October 2022\, the AAMI/FDA/BSI Annual Conference sought to discuss current knowledge and practical strategies to meet these new clinical evidence requirements. Dr. Sarah Chavez\, Criterion Edge Director of IVD Writing Services\, was honored to be an invited speaker. She joined with other regulatory\, notified body and industry leaders as panelists at the pre-conference workshop “New Requirements for In Vitro Diagnostics”. \nAttendees to this webinar will benefit from key insider insights gleaned from the Annual Conference\, as Sarah will be share and discuss the key take-aways from the Symposium\, including clinical evidence requirements and strategies to keep your report writing and data collection on track. Since most companies are in the early stages of planning for IVDR\, the goal of this webinar is to provide helpful suggestions for IVDR planning and preparation from the perspective of experienced regulatory writers. \nAt the end of the presentation\, we will dedicate 15 minutes to answering your questions. Please submit your questions beforehand if you have any to help us prepare. Also\, you can submit your questions at any point during the presentation. \nClick here to register for this session. \nWho should register for this webinar?\nThose Regulatory\, Quality and Clinical leaders and teams who develop\, write\, review or approve performance evaluation reports for IVDR submissions\, or anyone looking to learn more about new requirements for in vitro diagnostics. \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\, a new classification of IVDs\, 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. IVDs marketed in the EU will continue to require a CE Marking certificate to verify that the device meets all the regulatory requirements. Failure to meet the IVDR deadlines could be very costly to manufacturers that would either lose their CE Marking or fail to obtain one. Click here to read the full blog post that outlines the deadlines for manufacturers to become compliant with IVDR 2017/746.
URL:https://criterionedge.com/event/new-requirements-for-in-vitro-diagnostics-lessons-learned-from-the-aami-fda-bsi-annual-conference/
LOCATION:Webinar\, United States
CATEGORIES:IVDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/New-Requirements-for-In-Vitro-Diagnostics-cover-020123.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20221102T110000
DTEND;TZID=America/Los_Angeles:20221102T120000
DTSTAMP:20221024T194146Z
CREATED:20221024T194146Z
LAST-MODIFIED:20221024T194146Z
UID:3938-1667386800-1667390400@criterionedge.com
SUMMARY:Critical Concepts: A Deep Dive into MDR and IVDR Device Classification and Data Collection Strategies
DESCRIPTION:Critical Concepts: A Deep Dive into MDR and IVDR Device Classification and Data Collection Strategies\nIn September 2022\, European Commissioners published updates to the Manual on Borderline and Classification for Medical Devices\, which provides clarifications for classifying devices as medical or in vitro diagnostic devices under the MDR and IVDR. This guidance describes how to distinguish medical devices from medicinal products\, biocides\, and personal protective equipment\, and how to distinguish between in vitro diagnostic medical devices and general laboratory equipment. \nThis “Critical Concepts” webinar will discuss rules for device classification under each regulation\, as well as the risk-based classification rules as described in MDCH 2021-24 and MDCG 2020-16. Our “Deep Dive” will provide insights into the potential impact of risk-based classifications on your data collection strategies to support data sufficiency in the CER and PER. \nThere will be time at the end of the presentation to get your questions answered. Please submit your questions beforehand if you have any to help us prepare. Also\, you can submit your questions at any point during the presentation. \nClick here to register for this session. \nWho should register for this webinar?\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 these requirements is welcome to attend. \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\, a new classification of IVDs\, 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. IVDs marketed in the EU will continue to require a CE Marking certificate to verify that the device meets all the regulatory requirements. Failure to meet the IVDR deadlines could be very costly to manufacturers that would either lose their CE Marking or fail to obtain one. Click here to read the full blog post that outlines the deadlines for manufacturers to become compliant with IVDR 2017/746.
URL:https://criterionedge.com/event/critical-concepts-a-deep-dive-into-mdr-and-ivdr-device-classification-and-data-collection-strategies/
LOCATION:Webinar\, United States
CATEGORIES:IVDR Webinars,MDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/cover-with-date-Critical-Concepts-Deep-Dive-into-MDR-and-IVDR-Device-Classification.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;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;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: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: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: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: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