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Date/Time
Date(s) - 01/23/2020
12:30 pm - 5:30 pm CET

Location
Kursaal Bern

Categories

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 Global Product Development Strategy), 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?

Pricing:

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. ***

Event Details

If making a credit card payment, note that your profile address must match the credit card address on file.

Reservations are closed for this event.

12:30 - 13:00 PM Registration
13:00 - 14:00 PM Clinical Evidence for Medical Devices Under MDR: Is MEDDEV 2.7/1 revision 4 covering all needs? Presented by: Vincent Legay; Director of Global Product Development Strategy, NAMSA
14:00 - 15:00 PM Market Access and Reimbursement Challenges in Light of the New MDR Presented by: Marco Kalms; Founder & CEO, Kalms Consulting
15:30 - 16:30 PM Biocompatibility Under MDR: Is ISO 10993 sufficient to effectively claim GSPR compliance? Presented by: Vincent Legay; Director of Global Product Development Strategy, NAMSA
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 of 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. vlegay@namsa.com  
  Marco Kalms offers profound expertise in operational management, strategic approach, market access and reimbursement. In 2012, he founded Kalms Consulting, focusing on European market access for international medical device, diagnostic and bioscience companies. Marco has more than 25 years of experience in operational, strategic and market access leadership positions in the healthcare industry. As a long-time Sales Manager, Country Manager Germany and Managing Director Europe, he contributed significantly to the growth of American Medical Systems, Inc. In his role as Managing Director Europe, Marco developed market access strategies to open up new markets in the EMEA regions. It is this mixture of operational business and market access experience that is an essential part of the expertise the Kalms Consulting team offers to support healthcare companies. Many international clients have been benefiting from the services of Kalms Consulting for more than 7 years.