Medical Device Clinical Evaluation Reports - Webinar CD/Transcript

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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.

  • Medical Device Presidents and CEOs
  • Regulatory Affairs Management
  • Clinical Affairs Management
  • R&D Management

Michelle McDonough, Associate Director, Regulatory & Clinical Affairs at Musculoskeletal Clinical & Regulatory Advisers

Michelle McDonough joined MCRA in January 2009 and is responsible for drafting, reviewing, and strategizing US and international regulatory submissions including 510(k)s, PMAs, IDEs, pre-submissions, technical files, and Clinical Evaluation Reports, as well as management, design, and implementation of pre- and post-market clinical studies. Additionally, Michelle reviews company design history files, labeling, and clinical protocols for regulatory compliance, performs due diligence reviews of devices, designs and reviews pre-clinical and animal testing for device companies, develops initial and continuing review submissions for IRB approval, and oversees data management of clinical projects.