Webinar - Ensuring Compliance for your IVD’s Performance Evaluation

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2022Oct 12

Celegence - https://www.celegence.com/services/ivdr/ - is a global life science consulting firm focused solely on regulatory and quality compliance. We have the expertise to provide support for all of your In Vitro Diagnostic (IVD) regulatory needs; from strategic consulting, registration, device classification, PERs, to in country representation. The IVDR changes have strengthened the requirements for Performance Evaluations, which are conducted in the premarket phase. Further, it mandates that the performance of devices be continuously monitored throughout the life cycle of the device. The IVDR requires the continuous data collection, analysis and drafting of a Performance Evaluation Report (PER). Why should you read the watch this webinar? 1. To best understand the performance data requirements under the EU IVDR for IVDs 2. To Learn how the requirements could affect your current product lifecycle approach/QMS 3. To examine how to apply the industry best practices for systematic literature reviews 4. To find out the common pitfalls to avoid when drafting a PER for a smooth notified body or competent authority submission Celegence provides the medical device industry with consulting services that are tailored to the evolving needs of manufacturers. With our guidance, bringing your devices to the market and keeping them there will be easier for your regulatory and quality teams. You can reach out to us at info@celegence.com, contact us online or read more about Celegence’s medical device services: https://www.celegence.com/services/me...