Medical Device Clinical Evaluation Reports - Webinar CD/Transcript
Medical Device Clinical Evaluation Reports: Complying with European Guidelines
A CER is a living document — required for the EU market — that includes the clinical data, the appraisal and analysis stages of the evaluation, and conclusions regarding safety and performance.
Failing to make consistent updates to a CER could put your trial at risk.
Do you know:
- The new definition of sufficient clinical data?
- How to be compliant with the new device certification?
- The ongoing responsibilities for maintaining certification?
Join Michelle McDonough, Associate Director, Regulatory & Clinical Affairs at Musculoskeletal Clinical & Regulatory Advisers, as she provides practical, real-world tips on:
- What is considered sufficient clinical data and what happens if you supply insufficient clinical data
- The sometimes confusing components of CERs — and the consequences of noncompliance
- Expectations of the notified body assessors as they relate to CERs (hint, you better know the expectations)
- How these expectations are becoming more stringent
Order today to help ensure that your CERs are up to date.