Date(s) - 01/23/2020
12:30 pm - 5:30 pm CET
NAMSA is proud to present a half-day seminar dedicated to the learning of the EU’s Medical Device Regulation (MDR), followed by a networking happy hour.
This event, led by regulatory expert, Vincent Legay (NAMSA’s Director of Regulatory Consulting Services-EU), will explore the challenges and implications of MDR compliance from varying perspectives (Sponsors, Notified Bodies, Manufacturers, et. al.) to provide a forum for open discussion, learning and sharing of best practices and effective strategies for conformity.
Focus will be on two key areas where MDR represents the most significant impact for Sponsors:
- Clinical Evidence for Medical Devices under MDR
- Is MEDDEV 2.7/1 revision 4 covering all needs?
- Biocompatibility under MDR
- Is ISO 10993 sufficient to effectively claim General Safety and Performance Requirements (GSPR) compliance?
Regular Registration: € 150.00 ($165.00 USD)
*** NAMSA reserves the right to cancel 1 week prior to event in the event of low attendance. A full refund will be honored should this occur. ***
|12:30 - 13:00 PM||Registration|
|13:00 - 16:30 PM||Program|
|16:30 - 17:30 PM||Networking Happy Hour|
|Vincent Legay, holds a PhD in Biology and an executive Masters of Business Administration (MBA), and currently serves as NAMSA’s Director Global, Product Development Strategy. He possesses over 15 years’ experience at NAMSA where he has been responsible for regulatory consulting across the entire medical device lifecycle continuum. This expertise includes management of sterilization, biocompatibility, risk management, clinical evaluation and quality management systems for clients around the globe. Currently, he oversees a cross-functional team of medical device strategists across NAMSA Global entities and also directly supports medical device manufacturers with preclinical and clinical research approaches in an effort to meet regulatory business objectives. firstname.lastname@example.org|