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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
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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
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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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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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