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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
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ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
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