FDAnews Announces — New Brief — Winning Device EU Marketing Approval: Seven Steps to Writing Clinical Evaluation Reports

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EU regulations require devicemakers to submit a clinical evaluation report (CER) that presents data culled from development of approved devices similar to theirs and explains how the findings apply to their own product. This FDAnews Brief, Winning Device EU Marketing Approval walks readers through the process of developing and writing a CER with a 7-point model that ensures manufacturers cover all the bases and have the greatest chance of success.

Winning Device EU Marketing Approval:
Seven Steps to Writing Clinical Evaluation Reports
**An FDAnews Brief**
http://www.fdanews.com/WinningDeviceEUMarketingApproval    

If manufacturer want to market a device in Europe, they need to provide clinical evidence that the product is safe and effective. But if the development phase didn’t include clinical trials, how can they make that argument?

EU regulations require devicemakers to submit a clinical evaluation report (CER) that presents data culled from development of approved devices similar to theirs and explains how the findings apply to their own product.

It’s a tall order and a lengthy process, but a well-crafted CER can pay off in a marketing authorization certificate.

This FDAnews Brief walks readers through the process of developing and writing a CER with a 7-point model that ensures manufacturers cover all the bases and have the greatest chance of success. Readers will learn how to put together these elements of a strong CER:

1. Administrative information
2. State of the art overview
3. Equivalence evidence
4. Context and choice of clinical data
5. Summary of clinical data
6. Data analysis
7. Conclusion and supporting resources

Seven Steps to Writing Clinical Evaluation Reports provides practical lessons and advice manufacturers can use. Order the brief today.

Who Will Benefit:

  • Regulatory Affairs
  • Quality Control
  • Legal
  • Business Affairs

FDAnews Brief Details:
Winning Device EU Marketing Approval:
Seven Steps to Writing Clinical Evaluation Reports
Price: $177
http://www.fdanews.com/WinningDeviceEUMarketingApproval

Easy Ways to Order:
Online:     http://www.fdanews.com/WinningDeviceEUMarketingApproval            
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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