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DTSTART;TZID=America/Los_Angeles:20220928T110000
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DTSTAMP:20220929T213552Z
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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: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:20221026T110000
DTEND;TZID=America/Los_Angeles:20221026T120000
DTSTAMP:20221027T213857Z
CREATED:20221006T233131Z
LAST-MODIFIED:20221027T213857Z
UID:3928-1666782000-1666785600@criterionedge.com
SUMMARY:Critical Concepts: The Role of Post Market Surveillance in Establishing Data Sufficiency
DESCRIPTION:Critical Concepts: The Role of Post Market Surveillance in Establishing Data Sufficiency\nIn this webinar\, we will review the conformity requirements for “legacy devices” under the MDR and “established devices” under the IVDR to help you harness the potential of effective post market activities. We will discuss how “legacy devices\,” defined as those previously certified under MDD/AIMDD\, can demonstrate conformity to the general safety and performance requirements under the MDR through a collection of pre-market and post-market data. \nAdditionally\, we will touch on some examples of the types of clinical data that are appropriate to use for “legacy devices” for both MDR and IVDR requirements\, and finally we will review the MDCG 2020-6 guidance on clinical data for “legacy devices.” \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. You can also submit your questions during the presentation. \nClick here to watch the recording of this session. \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. \nPost Market Surveillance: Systematic Literature Review and Case Study\nJoining Criterion Edge’s President Laurie Mitchell\, is guest speaker\, Queenita Fernandes\, Medtronic’s Medical Safety Manager\, Patient Monitoring & Respiratory Interventions​. In this webinar\, we discuss how to deploy systematic literature review in order to augment post market clinical surveillance\, and share best tips on a robust systematic literature review process. Following this\, our guest speaker shares an informative case study illustrating more. \nKey Takeaways: \n\nHow leveraging published data can help meet regulatory expectations and inform internal decision-making​\nSteps for conducting a methodologically-sound SLR​\nHow data obtained through SLR can empower the successful execution of post-market surveillance activities\, drive efficiencies and support regulatory compliance.\n\nWatch this free webinar here.
URL:https://criterionedge.com/event/critical-concepts-the-role-of-post-market-surveillance-in-establishing-data-sufficiency/
LOCATION:Webinar\, United States
CATEGORIES:MDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/Critical-Concepts-The-Role-of-Post-Market-Activities-in-Establishing-Data-Sufficiency-102622.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:20230315T110000
DTEND;TZID=America/Los_Angeles:20230315T120000
DTSTAMP:20230301T013115Z
CREATED:20230301T013115Z
LAST-MODIFIED:20230301T013115Z
UID:4836-1678878000-1678881600@criterionedge.com
SUMMARY:Critical Concepts Medical Device Software: Approaches to Determining Risk Classification\, Qualification\, and Safety and Performance Outcomes
DESCRIPTION:In case you are wondering if Medical Device Software (MDSW/SaMD) and digital health content is a hot topic\, the FDA released 4 guidance documents in 2022 alone\, on topics ranging from cyber security\, medical image devices\, and mobile medical applications. Furthermore\, the European MDR- EU 2017/745 and new IVDR – EU 2017/746 regulation contain stipulations related to how software is regulated\, classified\, and qualified. \nYou may be asking yourselves:\n– Is my software considered a medical device?\n– How do I address the clinical evaluation for my medical device software?\n– How do I define the safety and performance outcomes\, and other clinical evaluation parameters? \nJoin us for answers to these questions and to find out more about the topic of software as a medical device! \nWatch the recording of this webinar here. \nWho should register for this webinar?\n\n\nThose Regulatory\, Quality and Clinical leaders and teams who develop\, write\, review or approve clinical evaluation reports for MDR submissions.
URL:https://criterionedge.com/event/critical-concepts-medical-device-software-approaches-to-determining-risk-classification-qualification-and-safety-and-performance-outcomes-3/
LOCATION:Webinar\, United States
CATEGORIES:MDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/Critical-Concepts-SaMD-031523.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20230405T110000
DTEND;TZID=America/Los_Angeles:20230405T120000
DTSTAMP:20230309T222838Z
CREATED:20230309T222838Z
LAST-MODIFIED:20230309T222838Z
UID:4837-1680692400-1680696000@criterionedge.com
SUMMARY:Developing Effective Patient-Focused Content: Writing Plain Language Lay Summaries and SSCP Patient Sections
DESCRIPTION:Healthcare companies continually strive to communicate important information about their drugs and devices to diverse audiences comprised of patients\, caregivers\, healthcare professionals (HCPs)\, and the general public. The use of plain language written communication can help ensure key health information and clinical research findings are understandable and accessible to all. \nIn this second presentation of our Deep-Dive: Plain Language Writing webinar series\, we will focus on best practices that guide the development of common forms of plain language communication for patients\, their families and/or caregivers\, such as the: \n\nPatient section of an EU MDR-compliant Summary of Safety and Clinical Performance (SSCP) for all Class III and Active Implantable Medical Devices (AIMD)\nPlain Language Summary (PLS) of a published journal article\nLay summaries required under EU CTR for clinical trials on medicinal products\n\nClick here to watch the recording of this webinar. \nLearning Objectives:\nJoin us as we discuss practical strategies you can use to develop effective patient-centered lay summary content such as: \nWho: Identify the target audience and the details and demographics of who they are.\nWhy: Why does the audience need to know the information?\nWhat: What are the goals of providing the content\, e.g.\, for information only\, to spur action\, or fulfill a regulatory requirement? What format is best suited to support the desired message and goal?\nHow: Identify the most appropriate dissemination channels for the information and any audience accessibility considerations.\nWhen: Determine any relevant timing strategies or requirements\, e.g.\, regulatory deadlines. \nWho is this webinar for?\nThose Medical\, Clinical\, and Scientific Affairs leaders and teams who are tasked with the development\, writing\, review or approval of plain language written content or deliverables targeted to patients\, their families and/or caregivers. \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 watch the recording of this webinar.  \nPlain Language Communication in Healthcare: Understanding the Requirements and Challenges of Plain Language Content Creation for Multiple Audiences\nHealthcare companies continually strive to communicate important information about their drugs and devices to diverse audiences comprised of patients\, caregivers\, healthcare professionals (HCPs)\, and the general public. The use of plain language written communication can help ensure key health information and clinical research findings are understandable and accessible to all.  ​ \nContent is the user experience.  Make your words count. \nWatch this recent webinar. \nKey Takeaways \n\nKey aspects that define plain language writing​\nPlain language content writing for multiple audiences​\nWhat is readability and suitability?​\nThe regulatory and legal requirements of plain language content​\nProject planning for publication of Plain Language Summaries
URL:https://criterionedge.com/event/developing-effective-patient-focused-content-writing-plain-language-lay-summaries-and-sscp-patient-sections-3/
LOCATION:Webinar\, United States
CATEGORIES:MDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/patient-focused-content-040523.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20230426T110000
DTEND;TZID=America/Los_Angeles:20230426T114500
DTSTAMP:20230412T211833Z
CREATED:20230412T211833Z
LAST-MODIFIED:20230412T211833Z
UID:4838-1682506800-1682509500@criterionedge.com
SUMMARY:Integration of Plain Language Content and Infographics into HCP Communication Channels: Strategies to Enhance HCP Engagement
DESCRIPTION:Healthcare companies continually strive to communicate important information about their drugs and devices to diverse audiences comprised of patients\, caregivers\, healthcare professionals (HCPs)\, and the general public. The use of plain language written communication can help ensure key health information and clinical research findings are understandable and accessible to all. \nBut you might wonder “Isn’t plain language intended only for patient and caregiver consumption? HCPs want factual\, scientifically rigorous content\, not the simplified messaging of plain language writing.” The answer is…. not always. The deliberate and targeted incorporation of plain language content into selected HCP communication channels can be an effective tool in in your omnichannel communication plan. \nClick here to watch the recording of this webinar. \nLearning Objectives:\nJoin us as we present information you can use to develop effective HCP-focused plain language content such as:\n1. Key elements of plain language content – what it is and what it isn’t\n2. How incorporation of plain language content into HCP-focused assets can create added value in HCP – patient interactions\n3. Common content formats that can be enhanced by the use of plain language content\n4. The elements of the Visual SRD and why HCPs prefer this format\n5. How innovative use of plain language \nWho is this webinar for?\nThose Medical\, Clinical\, and Scientific Affairs leaders and teams who are tasked with the development\, writing\, review or approval of plain language written content or deliverables targeted to healthcare professionals. \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 watch the recording of this webinar. \n\nDeveloping Effective Patient-Focused Content: Writing Plain Language Lay Summaries and SSCP Patient Sections\n\nHealthcare companies continually strive to communicate important information about their drugs and devices to diverse audiences comprised of patients\, caregivers\, healthcare professionals (HCPs)\, and the general public. The use of plain language written communication can help ensure key health information and clinical research findings are understandable and accessible to all. \nIn the second presentation of our Deep-Dive: Plain Language Writing webinar series\, we will focus on best practices that guide the development of common forms of plain language communication intended for the patient\, their families and/or caregivers\, such as the:\n• Patient section of an EU MDR-compliant Summary of Safety and Clinical Performance (SSCP) for all Class III and Active Implantable Medical Devices (AIMD)\n• Plain Language Summary (PLS) of a published journal article\n• Lay summaries required under EU CTR for clinical trials on medicinal products \nWatch this recent webinar. \nLearning Objectives \nWatch this webinar to learn practical strategies you can use to develop effective patient-centered lay summary content such as: \nWho: Identify the target audience and the details and demographics of who they are.\nWhy: Why does the audience need to know the information?\nWhat: What are the goals of providing the content\, e.g.\, for information only\, to spur action\, or fulfill a regulatory requirement? What format is best suited to support the desired message and goal?\nHow: Identify the most appropriate dissemination channels for the information and any audience accessibility considerations.\nWhen: Determine any relevant timing strategies or requirements\, e.g.\, regulatory deadlines.
URL:https://criterionedge.com/event/integration-of-plain-language-content-and-infographics-into-hcp-communication-channels-strategies-to-enhance-hcp-engagement-3/
LOCATION:Webinar\, United States
CATEGORIES:MDR Webinars
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20230503T110000
DTEND;TZID=America/Los_Angeles:20230503T114500
DTSTAMP:20230413T205725Z
CREATED:20230413T205725Z
LAST-MODIFIED:20230413T205725Z
UID:4839-1683111600-1683114300@criterionedge.com
SUMMARY:Ask the Expert: Plain Language Written Content for Multiple Audiences: Effective Communication for Patients\, Caregivers\, and HCPs
DESCRIPTION:Healthcare companies continually strive to communicate important information about their drugs and devices to diverse audiences comprised of patients\, caregivers\, healthcare professionals (HCPs)\, and the general public. The use of plain language written content ensures key health information and clinical research findings are understandable and accessible to all. \nIf you or your team are producing a high volume of these written documents for multiple audiences\, join us for this 45-minute live Q&A. We will discuss some of the most common challenges and best practices that your organization can implement to support your goals this year. \nQuestions may cover the key elements of plain language written content\, how to identify the target audience\, selecting the most appropriate dissemination channels for the information\, the challenges to produce a multitude of plain language written deliverables for multiple audiences\, and more. \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 note that answers will be limited to 3 minutes per question. This 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 Medical\, Clinical\, and Scientific Affairs leaders and teams who are develop write\, review or approve plain language written content or deliverables targeted to patients\, caregivers\, healthcare professionals (HCPs)\, and the general public. \nPlain Language Communication in Healthcare: Understanding the Requirements and Challenges of Plain Language Content Creation for Multiple Audiences\nMedical device manufacturers and pharma/biotech companies have a regulatory and legal obligation to convert key scientific content into plain language for lay audience consumption around the world. From producing clinical trial lay summaries for the general public to the action-focused informational content generation aimed at the Health Care Provider (HCP) audience\, the need to produce a multitude of plain language written deliverables has strained many already-stretched internal teams. How can your organization meet these challenges? \nWatch our recent webinar where we discuss the key aspects that define plain language writing​\, readability and suitability\, the regulatory and legal requirements of plain language content​\, and more.
URL:https://criterionedge.com/event/ask-the-expert-plain-language-written-content-for-multiple-audiences-effective-communication-for-patients-caregivers-and-hcps-3/
LOCATION:Virtual Q&A
CATEGORIES:MDR Webinars
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20230628T110000
DTEND;TZID=America/Los_Angeles:20230628T120000
DTSTAMP:20230623T182051Z
CREATED:20230623T182051Z
LAST-MODIFIED:20230623T182051Z
UID:4840-1687950000-1687953600@criterionedge.com
SUMMARY:It’s All Interconnected: Hidden Traps That Can Derail Your PER
DESCRIPTION:With the implementation of IVDR requirements\, IVD manufacturers have been challenged to align their internal processes and systems to comply with these rigorous regulations. In this practical presentation\, Criterion Edge uncovers what we have learned from our experience in writing MDR-compliant CERs\, and how urgently applicable some of these key learnings are in preparing a robust Performance Evaluation Report (PER).   \nThis presentation provides practical tips on how to assess for hidden traps and unexpected roadblocks that could impact the success of writing an IVDR-compliant PER. By performing a gap analysis and assessing the readiness and availability of critical resources\, documents and expertise\, you will be able to avoid project delays and discover efficiencies that will enable the on-time completion of a successful\, IVDR-compliant PER.  \nLearning Objectives:  \n\nThe importance of scoping your PER project in advance  \nThe critical inputs needed to enable the success of your PER and the impact to the project if these inputs are not available or incomplete  \nHow to identify those hidden gaps in resources and information and the steps to take to mitigate them\n\nClick here to watch the webinar recording and download the presentation slides. \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. \nAsk the Expert: Plain Language Written Content for Multiple Audiences: Effective Communication for Patients\, Caregivers\, and HCPs\nHealthcare companies continually strive to communicate important information about their drugs and devices to diverse audiences comprised of patients\, caregivers\, healthcare professionals (HCPs)\, and the general public. The use of plain language written content ensures key health information and clinical research findings are understandable and accessible to all. \nClick here to watch this recent webinar to learn key elements of plain language written content\, how to identify the target audience\, selecting the most appropriate dissemination channels for the information\, the challenges to produce a multitude of plain language written deliverables for multiple audiences\, and more.
URL:https://criterionedge.com/event/its-all-interconnected-hidden-traps-that-can-derail-your-per-3/
LOCATION:Webinar\, United States
CATEGORIES:MDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/cover-with-date-Its-All-Interconnected-Hidden-Traps-that-can-Derail-your-PER-webinar-062823.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: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: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: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:20250326T120000
DTEND;TZID=America/Chicago:20250326T130000
DTSTAMP:20250327T154949Z
CREATED:20250304T221601Z
LAST-MODIFIED:20250327T154949Z
UID:6651-1742990400-1742994000@criterionedge.com
SUMMARY:Maximizing the Value of Literature Reviews for Medical Device\, 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 good SLR 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 MDR 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 MDR 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\n 
URL:https://criterionedge.com/event/maximizing-the-value-of-literature-reviews-for-medical-device-from-competitive-intelligence-to-market-success/
LOCATION:Webinar\, United States
CATEGORIES:MDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/Webinar-Graphic-Mar-26th-20251.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Chicago:20250604T120000
DTEND;TZID=America/Chicago:20250604T130000
DTSTAMP:20260613T094529Z
CREATED:20250519T194523Z
LAST-MODIFIED:20260613T094529Z
UID:6703-1749038400-1749042000@criterionedge.com
SUMMARY:Leveraging AI in Regulatory Writing — Opportunities\, Oversight & What Medical Device Leaders Need to Know
DESCRIPTION:Artificial intelligence and large language models (LLMs) are transforming how medical device companies approach regulatory writing\, but questions remain around how to implement these tools effectively and responsibly\, and whether they actually save time and improve productivity.  \nIn this Ask the Expert session\, the team at Criterion Edge will explore how AI and LLMs can be used to improve the speed\, accuracy\, and cost-efficiency of regulatory and clinical writing tasks\, such as CERs\, PERs\, literature reviews\, and clinical data summaries. We’ll also examine how AI supports submission consistency across global markets like the U.S. and EU.  \nLearning Objectives   \n\nUnderstand how AI is being applied to accelerate regulatory writing workflows\, including CERs\, PERs\, and PMAs.\n\n\nExplore how AI can improve the efficiency and accuracy of systematic literature reviews and clinical data summaries.\n\n\nLearn what global regulatory agencies expect when AI is used in authoring or supporting submission documents.\n\n\nIdentify common risks and compliance considerations associated with AI-generated or AI-assisted content.\n\n\nGain a framework for evaluating AI-enabled vendors or service providers for regulatory writing support.\n\nWATCH NOW
URL:https://criterionedge.com/event/ask-the-expert-leveraging-ai-in-regulatory-writing-opportunities-oversight-what-medical-device-leaders-need-to-know/
LOCATION:Webinar\, United States
CATEGORIES:MDR Webinars
ATTACH;FMTTYPE=image/webp:https://criterionedge.com/wp-content/uploads/sjywx8mtykhpy6v0gimr.webp
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
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