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Post-Marketing Surveillance and CE Marketing
Session Chair(s)
Reinhard Berger, DRSc, MSc
Regulatory Affairs Medical Devices, Consulting-Advising, Austria
This session will focus on vigilance and post-market surveillance in the medical device field. You will learn the principles and methods from various perspectives – manufacturer, user and authorities. Participants will also learn about the different new approach in the medical device arena compared against pharma.
Speaker(s)
Reinhard Berger, DRSc, MSc
Regulatory Affairs Medical Devices, Consulting-Advising, Austria
Post-Market Surveillance – A Legal Requirement for Patient Safety and Benefit
Philippe Soly, MSN
Director of Global Regulations, European Authorised Representative, Philips Healthcare, France
Post-Market Surveillance – Compliance, Burden and Benefit with the Legal Requirements from a Manufacturer’s Perspective
Gerold Labek
President, European Arthroplasty Register Network (EARN), Switzerland
Wolfgang Lauer
Head of the Medical Devices Division, Federal Institute For Drugs and Medical Devices (bfarm), Germany
Post-Market Surveillance – A Legal Requirement for Patient Safety and Benefit
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