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SUMMARY:IVD Deep Dive Series Part 1
DESCRIPTION:Safety & Performance Objectives and Acceptance Criteria\nHow do I define acceptance criteria and how do I define safety and performance objectives?\nWhat are the biggest pitfalls or “Achille’s heels” to watch out for in identifying safety and performance measures? \nIn this webinar\, we’ll take a deep dive into the best practices to identify relevant and appropriate Safety and Performance Objectives and Acceptance Criteria for your Performance Evaluation Report (PER). First\, using a case study example\, we’ll discuss considerations and provide tips to help you select relevant Safety & Performance Objectives for your IVD. Additionally\, we’ll discuss how these objectives relate to the competitive landscape and State-of-the-Art (SOA) section of your PER. Then we’ll explain how these objectives help establish Acceptance Criteria\, a critical input for establishing the SOA in your PER. \nWatch the webinar recording. \nWho should watch this webinar?\nThose Regulatory\, Quality and Clinical leaders and teams who develop\, write\, review\, or approve performance evaluation reports for IVDR submissions. \n  \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 and a new classification of IVDs. Some other changes are 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. Consequently\, IVDs marketed in the EU will continue to require a CE Marking certificate. This is necessary to verify that the device meets all the regulatory requirements. Indeed\, failure to meet the IVDR deadlines could be very costly to manufacturers. They would either lose their CE Marking or fail to obtain one. \nRead more on this topic in our blog post\, here.
URL:https://criterionedge.com/event/ivd-deep-dive-series-part-1/
LOCATION:Webinar\, United States
CATEGORIES:IVDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/IVD-Deep-Dive-pt-1-cover-slide-030222.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
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