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SUMMARY:Demonstration of Sufficient Evidence and Regulatory Strategy Alignment in the Clinical Evaluation Process
DESCRIPTION:Demonstration of Sufficient Evidence and Regulatory Strategy Alignment in the Clinical Evaluation Process \nIn the first part of our webinar series\, we discussed Legacy Devices\, WET devices\, and devices exempt from Clinical Investigations under Article 61\, along with the need for data sufficiency and how significant changes impact the route to conformity. In this webinar\, our medical regulatory experts\, Dr. Sarah Chavez and Stacie Beecham\, discuss the concept of data sufficiency and give you strategies for addressing limited clinical and performance data. We also discuss adjusting the Clinical Evaluation Plan to align with the regulatory strategy.  How do you determine which content applies to each classification? How do you address data insufficiency for a WET or Legacy device? We answer these questions and outline how to ensure your regulatory strategy will adequately support the clinical evaluation specific to your device. \nClick here to watch the recording of this webinar. \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. \nHow to Empower Data-Driven Decisions in Your Organization\nEvery day\, pharma and medical device companies need data from Systematic Literature Reviews (SLRs) to inform\, direct\, and help drive their internal processes and decisions. Of course\, to comply with global regulatory requirements\, clinical literature is also required. Conducting SLRs to search\, screen\, and extract data from published sources can present challenges to your team in terms of expertise (e.g.\, medical librarian)\, methodology\, and resources. It takes trained people with the availability to screen\, review\, and analyze the literature. \nDownload our free white paper\, Systematic Literature Review: How to Empower Data-Driven Decisions in Your Organization to read more on this topic. \nYou can also watch our webinar on this topic. \nOur President Laurie Mitchell joins Jennifer Tetzlaff\, Research Product Specialist with Evidence Partners\, to talk to you about the following points: \n\nExamples of how the use of published data can support regulatory expectations\nWhen to conduct a systematic literature review\nBest practices for conducting a methodologically-sound SLR\nUse of available tools and technology
URL:https://criterionedge.com/event/demonstration-of-sufficient-evidence-and-regulatory-strategy-alignment-in-the-clinical-evaluation-process/
LOCATION:Webinar\, United States
CATEGORIES:MDR Webinars
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ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
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