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DTSTART;TZID=America/Chicago:20250305T120000
DTEND;TZID=America/Chicago:20250305T130000
DTSTAMP:20250306T175847Z
CREATED:20250218T235731Z
LAST-MODIFIED:20250306T175847Z
UID:6639-1741176000-1741179600@criterionedge.com
SUMMARY:The Current State of Medical Device Regulations: Strategies to Support a Successful Technical Documentation Assessment (TDA)
DESCRIPTION:Here we are\, nearly eight years after the publication of the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) and Medical Devices Regulation (EU) 2017/745 (MDR). As the May 2025 deadlines loom\, many manufacturers are facing the reality of what implementing these regulations actually entails. While the manufacturers seem to have been given more time\, a lack of clarity about clinical evidence expectations has left many companies struggling.   \nIn spite of these extended deadlines\, manufacturers continue to face challenges in implementing these regulations. Key pain points include:  \n\nEscalating costs of obtaining and maintaining certifications\, leading to budget uncertainty\nChallenges finding qualified regulatory affairs professionals and technical writers\nLack of clarity regarding clinical evidence requirements\nUnclear expectations from IVD and medical device Notified Bodies \n\nIn this webinar\, we will discuss strategies to support your Regulatory Affairs team as they strive to meet the requirements for technical documentation\, drawing from our experience with clinical evidence expectations for the Performance/Clinical Evaluation Reports (PERs/CERs) and Post Market Surveillance Reports for a wide range of medical devices and IVDs.  \nLearning objectives:   \n\nDiscuss common challenges (and deficiencies) identified during the Notified Body review of the PER/CER and PMS reports.\nExplain how Technical Documentation Assessments (TDA) can affect your timeline for certification.\nProvide real-world examples to illustrate the cost-effectiveness of preparing and planning for these extensive requirements early in your product’s lifecycle.\nDescribe our approach to meeting clinical evidence expectations through well-defined research questions\, targeted systematic literature reviews\, and well-organized templates.\n \n\nWATCH NOW
URL:https://criterionedge.com/event/the-current-state-of-medical-device-regulations-strategies-to-support-a-successful-technical-documentation-assessment-tda/
LOCATION:Webinar\, United States
CATEGORIES:IVDR Webinars,MDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/Webinar-Graphic-Mar-5th-2025-v1.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Chicago:20250326T120000
DTEND;TZID=America/Chicago:20250326T130000
DTSTAMP:20250327T154949Z
CREATED:20250304T221601Z
LAST-MODIFIED:20250327T154949Z
UID:6651-1742990400-1742994000@criterionedge.com
SUMMARY:Maximizing the Value of Literature Reviews for Medical Device\, From Competitive Intelligence to Market Success
DESCRIPTION:A well-executed systematic literature review (SLR) is more than just a regulatory compliance requirement—it’s a strategic asset for your entire organization. In this webinar\, we’ll explore how a good SLR can support regulatory submissions\, enhance competitive intelligence\, and facilitate post-market surveillance while saving time\, money\, and resources. Using real-world examples\, our experts will share best practices for designing an effective SLR that meets FDA and MDR requirements and serves as a valuable tool for R&D\, regulatory\, and marketing teams.  \nLearning Objectives:  \n\nUncover the Hidden Advantages of SLRs: Learn why a methodologically sound systematic literature review (SLR) outperforms traditional internet searches—and how it provides more credible\, comprehensive\, and actionable insights. \n\n\nMaster the Art of Search Strategy: Discover expert techniques for selecting the right keywords\, refining search criteria\, and optimizing data collection to ensure your SLR is both thorough and highly relevant to regulatory and business needs. \n\n\nTurn Published Data into a Strategic Asset Across the Organization: Explore how leveraging existing literature not only meets FDA and MDR expectations but also informs internal decision-making across teams\, competitive positioning\, and risk assessment. \n\n\nSee the Impact in Action: Through the examination of real-world scenarios\, you will gain a deeper understanding of how different teams—from R&D and regulatory affairs to marketing—can extract value from a well-executed SLR to drive smarter business and compliance strategies. \n\nWATCH NOW\n 
URL:https://criterionedge.com/event/maximizing-the-value-of-literature-reviews-for-medical-device-from-competitive-intelligence-to-market-success/
LOCATION:Webinar\, United States
CATEGORIES:MDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/Webinar-Graphic-Mar-26th-20251.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Chicago: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: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: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/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/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
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