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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
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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
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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
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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
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