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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/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: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: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
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