2016 Webinar by Compliance4all on Clinical Evaluation Reports
- Start Date:
- Wednesday, 14 December, 2016
- End Date:
- Wednesday, 14 December, 2016 11:00am
- Health & Nutrition
Overview: 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 CERPrepare and execute a literature reviewDefine the elements comprising the CER and recommended formatConstruct 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 otherwiseLearn 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.QA/ComplianceRegulatory Affairs Management and RA SpecialistsMarketingConsultants 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: +1-800-447-9407Email: support@compliance4All.comhttp://www.compliance4all.com/Event Link : http://www.compliance4all.com/control/w_product/~product_id=500841LIVE?channel=mailer&camp=webinar&AdGroup=meetings4docs_Dec_2016_SEOTwitter Follow us - https://twitter.com/compliance4allFacebook Like us - https://www.facebook.com/Compliance4allLinkedIn Like us - https://www.linkedin.com/company/compliance4all
161 Mission Falls Lane,
Conference organized by Compliance4ALL
Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. .Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements. Compliance4All offers path breaking professional training solutions to organizations that help them address pain areas and overcome the challenges and difficulties associated with meeting regulatory requirements.
- 161 Mission Falls Lane, Suite 216