FDAnews Announces — Medical Device Clinical Evaluation Reports: Complying with European Guidelines Webinar, June 14, 2016

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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. CERs are being subjected to more intense scrutiny in the conformity assessment phase and post-market phase than ever before.

Medical Device Clinical Evaluation Reports:
Complying with European Guidelines
June 14, 2016 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/mdclinicalevaluationreports            

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 the trial at risk.

CERs are being subjected to more intense scrutiny in the conformity assessment phase and post-market phase than ever before.

What enhanced data evaluation is required for CERs?

What are the ongoing responsibilities for maintaining certification?

Join Michelle McDonough, Associate Director, Regulatory and Clinical Affairs at Musculoskeletal Clinical & Regulatory Advisers, on June 14 as she provides valuable insights on:

  •     What is considered sufficient clinical data and what happens if insufficient clinical data is supplied
  •     The sometimes confusing components of CERs — and the consequences of noncompliance
  •     Expectations of the notified body assessors as they relate to CERs
  •     How these expectations are becoming more stringent

Register today to help ensure that the CERs are up to date.

Meet the Presenter:
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.

Who Will Benefit:

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

Webinar Details:
Medical Device Clinical Evaluation Reports:
Complying with European Guidelines
June 14, 2016 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/mdclinicalevaluationreports

Tuition:
$287 per site

Easy Ways to Register:
Online:     http://www.fdanews.com/mdclinicalevaluationreports        
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
+1 (703) 538-7665
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