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Medical Devices in Europe 2016 - Web Conference by Compliance4all on Clinical Evaluation Reports



VenueOnline, USA - United States USA - United States

KeywordsClinical Evaluation Reports; Global Harmonization; Clinical Evaluation Report


Topics/Call fo Papers

As industry is aware of, now you must deal with the new requirements for Clinical Evaluation Reports (CER's) if you sell all classes of medical devices in Europe. As of March 21, 2010 all medical devices, including Class I and Class IIa, will be required.
Areas Covered in the Session:
Understand the Essential Requirements and the relationship to the CER
Prepare and execute a literature review
Define the elements comprising the CER and recommended format
Construct and manage the Technical File
Understand the expectation that devices sold in Europe must have a CER in it's Tech File unless you justify otherwise
Learn what resources exist to guide you in developing a clinical evaluation report, including how to select a format for writing it and keeping it updated
Who Will Benefit:
This webinar will provide valuable assistance and guidance to companies who need to better understand the goal of the CER, the format and contents. The employees who will benefit include:
All end-users from appropriate departments who desire or require a better understanding or a refresh knowing that every medical device sold in Europe must be supported with a Clinical Evaluation Report in its technical file.
Regulatory Affairs Management and RA Specialists
Clinical Affairs
Speaker Profile:
David Dills , Global Regulatory Affairs & Compliance Consultant, has an accomplished record with more than 26 years of experience within regulatory affairs, compliance and quality consultative services for early-stage/established Class I/II/III medical devices, IVDs, and bio/pharmaceutical manufacturers on the global landscape.
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Event Link :
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Last modified: 2016-11-03 14:35:08