BEGIN:VCALENDAR VERSION:2.0 PRODID:-//Criterion Edge - ECPv6.18.3//NONSGML v1.0//EN CALSCALE:GREGORIAN METHOD:PUBLISH X-WR-CALNAME:Criterion Edge X-ORIGINAL-URL:https://criterionedge.com X-WR-CALDESC:Events for Criterion Edge REFRESH-INTERVAL;VALUE=DURATION:PT1H X-Robots-Tag:noindex X-PUBLISHED-TTL:PT1H BEGIN:VTIMEZONE TZID:America/Los_Angeles BEGIN:DAYLIGHT TZOFFSETFROM:-0800 TZOFFSETTO:-0700 TZNAME:PDT DTSTART:20210314T100000 END:DAYLIGHT BEGIN:STANDARD TZOFFSETFROM:-0700 TZOFFSETTO:-0800 TZNAME:PST DTSTART:20211107T090000 END:STANDARD BEGIN:DAYLIGHT TZOFFSETFROM:-0800 TZOFFSETTO:-0700 TZNAME:PDT DTSTART:20220313T100000 END:DAYLIGHT BEGIN:STANDARD TZOFFSETFROM:-0700 TZOFFSETTO:-0800 TZNAME:PST DTSTART:20221106T090000 END:STANDARD BEGIN:DAYLIGHT TZOFFSETFROM:-0800 TZOFFSETTO:-0700 TZNAME:PDT DTSTART:20230312T100000 END:DAYLIGHT BEGIN:STANDARD TZOFFSETFROM:-0700 TZOFFSETTO:-0800 TZNAME:PST DTSTART:20231105T090000 END:STANDARD BEGIN:DAYLIGHT TZOFFSETFROM:-0800 TZOFFSETTO:-0700 TZNAME:PDT DTSTART:20240310T100000 END:DAYLIGHT BEGIN:STANDARD TZOFFSETFROM:-0700 TZOFFSETTO:-0800 TZNAME:PST DTSTART:20241103T090000 END:STANDARD BEGIN:DAYLIGHT TZOFFSETFROM:-0800 TZOFFSETTO:-0700 TZNAME:PDT DTSTART:20250309T100000 END:DAYLIGHT BEGIN:STANDARD TZOFFSETFROM:-0700 TZOFFSETTO:-0800 TZNAME:PST DTSTART:20251102T090000 END:STANDARD BEGIN:DAYLIGHT TZOFFSETFROM:-0800 TZOFFSETTO:-0700 TZNAME:PDT DTSTART:20260308T100000 END:DAYLIGHT BEGIN:STANDARD TZOFFSETFROM:-0700 TZOFFSETTO:-0800 TZNAME:PST DTSTART:20261101T090000 END:STANDARD BEGIN:DAYLIGHT TZOFFSETFROM:-0800 TZOFFSETTO:-0700 TZNAME:PDT DTSTART:20270314T100000 END:DAYLIGHT BEGIN:STANDARD TZOFFSETFROM:-0700 TZOFFSETTO:-0800 TZNAME:PST DTSTART:20271107T090000 END:STANDARD END:VTIMEZONE BEGIN:VTIMEZONE TZID:America/Chicago BEGIN:DAYLIGHT TZOFFSETFROM:-0600 TZOFFSETTO:-0500 TZNAME:CDT DTSTART:20230312T080000 END:DAYLIGHT BEGIN:STANDARD TZOFFSETFROM:-0500 TZOFFSETTO:-0600 TZNAME:CST DTSTART:20231105T070000 END:STANDARD BEGIN:DAYLIGHT TZOFFSETFROM:-0600 TZOFFSETTO:-0500 TZNAME:CDT DTSTART:20240310T080000 END:DAYLIGHT BEGIN:STANDARD TZOFFSETFROM:-0500 TZOFFSETTO:-0600 TZNAME:CST DTSTART:20241103T070000 END:STANDARD BEGIN:DAYLIGHT TZOFFSETFROM:-0600 TZOFFSETTO:-0500 TZNAME:CDT DTSTART:20250309T080000 END:DAYLIGHT BEGIN:STANDARD TZOFFSETFROM:-0500 TZOFFSETTO:-0600 TZNAME:CST DTSTART:20251102T070000 END:STANDARD BEGIN:DAYLIGHT TZOFFSETFROM:-0600 TZOFFSETTO:-0500 TZNAME:CDT DTSTART:20260308T080000 END:DAYLIGHT BEGIN:STANDARD TZOFFSETFROM:-0500 TZOFFSETTO:-0600 TZNAME:CST DTSTART:20261101T070000 END:STANDARD END:VTIMEZONE BEGIN:VEVENT DTSTART;TZID=America/Los_Angeles:20261028T080000 DTEND;TZID=America/Los_Angeles:20261028T090000 DTSTAMP:20261028T185441Z CREATED:20261028T183219Z LAST-MODIFIED:20261028T185441Z UID:12147-1793174400-1793178000@criterionedge.com SUMMARY:Beyond AI: Why the Future of Scientific and Regulatory Writing Is Human + AI DESCRIPTION:AI is becoming increasingly common in scientific and regulatory writing\, but using it effectively requires more than simply automating existing workflows. In regulated environments\, teams must balance AI-driven efficiency with scientific judgment\, evidence traceability\, quality control\, and human accountability. \nIn this webinar\, Criterion Edge explores a human + AI approach to scientific and regulatory writing\, including where AI can improve efficiency\, where it introduces risk\, and how teams can integrate AI without compromising regulatory rigor. \n\nUnderstand Where AI Adds Value—and Where It Falls Short\nExplore how AI can assist with literature screening\, data extraction\, drafting\, and error detection\, as well as common risks such as hallucinated citations\, missing evidence\, and incorrect clinical context.\nMaintain Regulatory Rigor and Evidence Traceability\nLearn why AI-assisted regulatory writing still requires documented methodologies\, reproducible evidence trails\, expert verification\, and human accountability throughout the workflow.\nBuild a Practical Human + AI Workflow\nDiscover how to introduce AI strategically\, validate outputs\, strengthen QC processes\, and use scientific experts for the higher-level interpretation and decision-making AI cannot replace.\n\nWatch Now URL:https://criterionedge.com/event/beyond-ai-why-the-future-of-scientific-and-regulatory-writing-is-human-ai/ LOCATION:Webinar\, United States CATEGORIES:IVDR Webinars,MDR Webinars,Pharma Webinars ATTACH;FMTTYPE=image/jpeg:https://criterionedge.com/wp-content/uploads/zoom-webinar-graphic-261028.jpg ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com END:VEVENT BEGIN:VEVENT DTSTART;TZID=America/Los_Angeles:20260923T080000 DTEND;TZID=America/Los_Angeles:20260923T090000 DTSTAMP:20261028T184230Z CREATED:20260923T141200Z LAST-MODIFIED:20261028T184230Z UID:11387-1790150400-1790154000@criterionedge.com SUMMARY:Turn Scientific Information into Organization-Wide Insights with AI DESCRIPTION:As scientific literature continues to grow\, traditional systematic literature reviews (SLRs) can leave valuable insights siloed in individual reports. AI-powered evidence intelligence can help life sciences teams make scientific evidence more accessible\, reusable\, and actionable across the organization. \nIn this webinar\, our experts explore how pharmaceutical and medical device companies can combine AI\, systematic literature review methodology\, and human scientific expertise to improve evidence management\, support regulatory readiness\, and reduce duplicated effort. \n\nMove Beyond One-Time Literature Reviews\nLearn how continuous literature monitoring can help teams identify emerging evidence\, risks\, gaps\, competitor activity\, and changes in the state of the art.\nUnderstand Where AI Fits in the SLR Process\nExplore how AI can support literature discovery\, screening\, categorization\, and summarization—while experienced scientists provide the interpretation and regulatory context needed to maintain rigor.\nCreate a Shared Evidence Foundation Across Teams\nDiscover how structured\, reusable evidence can support Regulatory Affairs\, Medical Affairs\, R&D\, and Clinical teams while improving consistency and efficiency.\n\nWatch Now URL:https://criterionedge.com/event/turn-scientific-information-into-organization-wide-insights-with-ai/ LOCATION:Webinar\, United States CATEGORIES:Pharma Webinars ATTACH;FMTTYPE=image/webp:https://criterionedge.com/wp-content/uploads/Turn-Scientific-Information-into-Organization-Wide-Insights-with-AI-scaled.webp ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com END:VEVENT BEGIN:VEVENT DTSTART;TZID=America/Chicago:20250924T120000 DTEND;TZID=America/Chicago:20250924T130000 DTSTAMP:20260613T094449Z CREATED:20250821T152527Z LAST-MODIFIED:20260613T094449Z UID:7139-1758715200-1758718800@criterionedge.com SUMMARY:Maximizing the Value of Literature Reviews in Pharma\, From Competitive Intelligence to Market Success DESCRIPTION:In the pharmaceutical industry\, systematic literature reviews (SLRs) can be a valuable tool — not just for regulatory submissions\, but as a strategic foundation for drug development\, clinical trial design\, and commercialization\, feasibility\, supporting IND/NDA filings\, and identifying unmet needs. Understanding the full scope of their strategic value can help teams align evidence generation with business objectives and regulatory demands. \nIn this webinar\, our experts will show how pharmaceutical companies can unlock the full potential of SLRs to support regulatory requirements\, inform internal decision-making\, and improve competitive positioning. Using real-world pharmaceutical-focused examples\, we’ll discuss when and how to deploy an SLR\, and the benefits of working with experienced external partners like Criterion Edge to streamline timelines and elevate quality. \n\nUnderstand the Strategic Role of SLRs in Pharmaceutical and Combination Device Development\nLearn how SLRs support regulatory filings while also guiding early-stage development\, clinical planning\, and lifecycle management. Understanding the full scope of their strategic value can help teams align evidence generation with business objectives and regulatory demands.\nDesign an SLR That Serves Both Regulatory and Commercial Goals\nDiscover how a well-designed search methodology improves evidence quality and generates insights that can also be leveraged by cross-functional teams—from R&D and Medical Affairs to Sales and Marketing. For executives overseeing cross-functional teams\, aligning SLR outputs to multiple internal stakeholders increases the ROI of evidence generation efforts and reduces redundancy.\nKnow When to Bring in the Experts\nIdentify when your internal team may benefit from partnering with an experienced team like Criterion Edge to ensure scientific rigor\, regulatory alignment\, and delivery of publication- or submission-ready outputs. Understanding when and why to outsource can help executives mitigate delays and improve quality across submissions\, strategy decks\, and decision-support materials.\n\nWATCH NOW URL:https://criterionedge.com/event/maximizing-the-value-of-literature-reviews-in-pharma-from-competitive-intelligence-to-market-success/ LOCATION:Webinar\, United States CATEGORIES:Pharma Webinars ATTACH;FMTTYPE=image/webp:https://criterionedge.com/wp-content/uploads/scukxxqtmpeiazorv8kj.webp 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 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 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: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:20241211T120000 DTEND;TZID=America/Chicago:20241211T130000 DTSTAMP:20241205T224448Z CREATED:20241108T165200Z LAST-MODIFIED:20241205T224448Z UID:6581-1733918400-1733922000@criterionedge.com SUMMARY:Overcoming Deadline Bottlenecks in Pharma: How a Writing Team Can Help DESCRIPTION:Overview\nIn the fast-paced environment of pharmaceutical development\, project demands often outstrip available resources\, leading to critical bottlenecks in deliverables. Teams frequently find themselves finishing one clinical study and needing to pivot to the next project development\, leaving tasks like CSR completion sidelined. Additionally\, competing priorities\, from regulatory requirements to study design revisions\, can push essential writing deliverables to the back burner. By leveraging the skills and expertise of an experienced writing team\, companies can ensure the timely completion of documents and maintain project momentum without compromising quality. \nLearning Objectives \n\nExplore common bottlenecks in pharmaceutical documentation workflows and their impact.\nUnderstand the added value of external medical writing teams to alleviate internal resource constraints and improve efficiency.\nLearn strategies for integrating external writing and project management support into ongoing projects to ensure timely completion of critical documents like CSRs\, IBs\, and protocols. \n\n  \nRESERVE YOUR SPOT\n  URL:https://criterionedge.com/event/overcoming-deadline-bottlenecks-in-pharma-how-a-writing-team-can-help/ LOCATION:Webinar\, United States CATEGORIES:Pharma Webinars ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/Wednesday-11th-2024-v2.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:20240828T120000 DTEND;TZID=America/Chicago:20240828T124500 DTSTAMP:20240904T173823Z CREATED:20240813T214236Z LAST-MODIFIED:20240904T173823Z UID:6301-1724846400-1724849100@criterionedge.com SUMMARY:Ask the Expert: The Role of Real-World Evidence (RWE) in Regulatory Submissions DESCRIPTION:Welcome to our Ask The Expert series\, where the Criterion Edge team of experts take your questions on trending industry topics relevant to the work you do every day.  From global regulatory challenges\, clinical evidence issues or regulatory writing best practices\, the goal of this Q&A format is to share information\, ideas and solutions. \nToday’s conversation tackles the rapidly evolving landscape of Real World Evidence and its potential use in global regulatory submissions\, as we discussed in our July 31st Pharma In Focus: The Role of Real World Evidence in Regulatory Submissions webinar. \nBring your questions and join the conversation! \n  \nWATCH WEBINAR URL:https://criterionedge.com/event/ask-the-expert-the-role-of-real-world-evidence-rwe-in-regulatory-submissions/ LOCATION:Webinar\, United States ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/Webinar-8_28_2024-dr-Sheila-Grab-v4.png ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com END:VEVENT BEGIN:VEVENT DTSTART;TZID=America/Chicago:20240814T120000 DTEND;TZID=America/Chicago:20240814T130000 DTSTAMP:20240815T221931Z CREATED:20240724T231756Z LAST-MODIFIED:20240815T221931Z UID:6285-1723636800-1723640400@criterionedge.com SUMMARY:Emerging Trends in Global Regulations: Insights Into More Efficient Regulatory Writing Practices DESCRIPTION:Join us for an insightful and interactive webinar where we explore the ever-evolving landscape of global regulatory trends and their impact on information across all industries. As regulations governing product development\, agency interactions\, and filing for product approvals become increasingly complex and geographically diverse\, regulatory professionals and medical writers must adapt to ensure the compliance\, clarity and effectiveness of their documentation to meet the intended needs. This session will equip you with the background and practical insights needed to effectively understand and adapt to these regulatory changes.   \nLearning Objectives   \n\nRegulations then and now: Examine the historical and ongoing changes in global regulations and how these regulatory evolutions have reshaped the structure and content of key regulatory reports. \n\n\nRegional differences? Gain insights into how regional regulatory variations influence writing practices and help you understand the needs of the intended audience. \n\n\nWhat is the impact? Understand how these regulatory evolutions have reshaped the structure and content of key regulatory reports and documents. \n\n\nPractical strategies that support writing efficiency: Learn strategies to tailor your internal writing processes to meet the expectations and requirements of different geographic audiences to ensure your documents remain relevant and compliant.  \n\n  \nWho Should Attend and Why?  \nThis webinar is ideal for regulatory professionals\, regulatory writers\, medical writers\, compliance officers\, and anyone involved in the preparation and review of regulatory documentation who want to know more about how to:  \n\nStay abreast of how evolving regulatory requirements can affect your internal processes and written documents and reports. \n\n\nIdentify new strategies to efficiently produce compliant\, high-quality regulatory documents. \n\n\nLearn from experts with extensive experience producing documents and reports for a variety of global regulatory authorities. \n\n  \nWATCH NOW URL:https://criterionedge.com/event/emerging-trends-in-global-regulations-insights-into-more-efficient-regulatory-writing-practices/ LOCATION:Webinar\, United States ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/Webinar-14-8.png ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com END:VEVENT BEGIN:VEVENT DTSTART;TZID=America/Chicago:20240731T120000 DTEND;TZID=America/Chicago:20240731T130000 DTSTAMP:20240815T202124Z CREATED:20240708T164629Z LAST-MODIFIED:20240815T202124Z UID:6193-1722427200-1722430800@criterionedge.com SUMMARY:Pharma in Focus: The Role of Real-World Evidence (RWE) in Regulatory Submissions DESCRIPTION:In this webinar\, we will explore the strategic use of Real-World Evidence (RWE) throughout product development. Participants will learn about the integration of RWE from various sources and how it can be used to bolster regulatory submissions. \nLearning Objectives: \n\nUnderstand the sources of Real-World Data (RWD) which are used to generate RWE\nExplore the main uses of RWE throughout the development[SG1]  process\nIdentify strengths and pitfalls when using RWE in regulatory submissions\n\nWATCH NOW URL:https://criterionedge.com/event/pharma-in-focus-the-role-of-real-world-evidence-rwe-in-regulatory-submissions/ LOCATION:Webinar\, United States ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/July-31-2024-v2.png ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com END:VEVENT BEGIN:VEVENT DTSTART;TZID=America/Chicago:20240717T120000 DTEND;TZID=America/Chicago:20240717T130000 DTSTAMP:20240815T202522Z CREATED:20240618T193655Z LAST-MODIFIED:20240815T202522Z UID:5811-1721217600-1721221200@criterionedge.com SUMMARY:Trending Topics: From the AI Act to Orphan Devices\, Key Takeaways from RAPS EU Convergence 2024 DESCRIPTION:Welcome to our new Trending Topics webinar series! Each webinar in this series will present key trending topics\, late-breaking regulatory news and other hot-button topics from medical and in vitro device industry leaders. Tap into the critical conversations that are shaping the future of the MedTech industry and join us as we explore current issues\, trending conversations and decisions impacting the MedTech regulatory space. \nIn this webinar\, we will discuss a few of the key trending topics and issues discussed at the RAPS EU Convergence conference in Berlin. Topics include: \n1. The AI Act and MDR: identify the challenges\, incompatibilities and conflicts that arise from applying both frameworks to AI-based medical devices.\n2. Innovative and Orphan Devices: an expert panel suggests developing MDR special conformity assessment pathways to support the unique regulatory challenges faced by orphan and innovative medical devices.\n3. Notified Body Acknowledge Challenges: from inconsistent opinions to EUDAMED delays\, notified bodies continue to face numerous challenges in the current regulatory landscape. What can be done?\n4. The Impact of “massive procrastination” of MDR and IVDR Dossier Submissions: notified body experts are concerned at the potential constraints to future device availability as applications to the Notified Bodies decline in the wake of deadline extensions.\n5. Updates from the IMDRF Working Groups: review the latest updates to the scope and objectives a broad range of guidance documents on topics ranging from artificial intelligence / machine learning (AI/ML)\, good regulatory review practices\, adverse event (AE) terminology\, quality management systems\, personalized medical devices\, and software as a medical device\, and discuss their achievements and challenges. \nWATCH NOW URL:https://criterionedge.com/event/trending-topics-from-the-ai-act-to-orphan-devices-key-takeaways-from-raps-eu-convergence-2024/ LOCATION:Webinar\, United States ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/July-17-2024.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:20240605T120000 DTEND;TZID=America/Chicago:20240605T130000 DTSTAMP:20240815T202717Z CREATED:20240522T170848Z LAST-MODIFIED:20240815T202717Z UID:5175-1717588800-1717592400@criterionedge.com SUMMARY:Understanding FDA: Essentials for Briefing Books in Pre-IND\, Pre-NDA\, and Pre-BLA Meetings DESCRIPTION:Join Criterion Edge on June 5th\, 2024\, at 12 PM CST for an enlightening session with Geoff Fatzinger\, our Senior Regulatory Consultant. Dive deep into the essentials of FDA interactions in our webinar: “Understanding FDA: Essentials for Briefing Books in Pre-IND\, Pre-NDA\, and Pre-BLA Meetings.” Uncover the intricacies of FDA expectations and learn how to craft effective briefing books tailored for success in pre-IND\, pre-NDA\, and pre-BLA meetings. From interpreting FDA requirements to tailoring your submissions\, this webinar is your gateway to mastering FDA regulatory engagements. \nLearning Objectives: \nInterpreting FDA Expectations:\n● Develop a clear understanding of the FDA’s expectations during pre-IND\, pre-NDA\, and pre-BLA interactions.\n● Navigate the nuances of FDA requirements for compliance. \nBuilding Effective Briefing Books:\n● Identify and comprehend the key components integral to crafting briefing books.\n● Learn best practices for organizing information to facilitate communication with the FDA. \nTailoring Briefing Books for FDA Meetings:\n● Explore considerations when tailoring briefing books to align with the FDA’s unique review processes.\n● Understand how to address FDA preferences and requirements for optimized submissions. \nAchieving Success in FDA Interactions:\n● Overcome common challenges encountered in FDA meetings and briefing book preparation.\n● Gain insights into practical strategies for navigating the FDA regulatory landscape. \nJoin us for this informative webinar on FDA interactions\, where our expert will share valuable insights to enhance your briefing book preparation for successful engagements with the FDA. \nWATCH NOW URL:https://criterionedge.com/event/understanding-fda-essentials-for-briefing-books-in-pre-ind-pre-nda-and-pre-bla-meetings/ LOCATION:Webinar\, United States ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/June-5-2024.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: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/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: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: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: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: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:20230208T100000 DTEND;TZID=America/Los_Angeles:20230208T110000 DTSTAMP:20230222T164434Z CREATED:20230203T004038Z LAST-MODIFIED:20230222T164434Z UID:4216-1675850400-1675854000@criterionedge.com SUMMARY:Plain Language Communication in Healthcare Part 1 Webinar DESCRIPTION:Plain Language Communication in Healthcare – Part 1: Understanding the Requirements and Challenges of Plain Language Content Creation for Multiple Audiences\nHealthcare companies such as medical 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? \nThis first presentation in a three-part Deep-Dive Plain Language series from Criterion Edge examines: \n• Key aspects that define plain language writing\n• The regulatory and legal requirements of plain language content\n• Plain language writing for multiple audiences\, e.g.\, lay audience versus Health Care Providers (HCPs)\n• Solutions to common pain points\, for example\, standardizing key messaging across multiple written deliverables and platforms \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 session. URL:https://criterionedge.com/event/plain-language-communication-in-healthcare-part-1-webinar/ LOCATION:Webinar\, United States ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/Plain-Language-Communication-in-Healthcare-part-1-webinar-020823.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: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: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:20220928T110000 DTEND;TZID=America/Los_Angeles:20220928T120000 DTSTAMP:20220929T213552Z CREATED:20220916T221535Z LAST-MODIFIED:20220929T213552Z 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 END:VCALENDAR