Date(s) - 03/28/2019
9:30 am - 3:00 pm CET
NAMSA is proud to present a one-day seminar dedicated to the EU Medical Device Regulation (MDR). With MDR compliance timeframes quickly approaching, manufacturers should already be in the process of implementing their transition plans. This small, intimate gathering will offer attendees the opportunity to gain knowledge from industry experts, including from the perspective of a Notified Body. Throughout this summit, presenters will explore the challenges and implications of MDR compliance from all angles and provide a wide forum for discussion and learning.
(Registration will take place from 9:30 – 10:00, with a brief welcome at 10:00 and networking time throughout the day.)
10:15 – 11:15 | NAMSA Perspective: “MDR Transition Plan: Do You Have the Elements in Place?”
Presented by: Mr. Adrian Keene, Director – Product Development Strategy, NAMSA
11:30 – 12:30 | BSI Perspective: “Notified Body Expectations from Manufacturers’ Implementation of MDR”
Presented by: Mr. Gjalt Bosma, Scheme Manager and Product Specialist, BSI
12:30 – 13:30 | Lunch
13:30 – 14:30 | Industry Perspective: “Challenges and Chances – New Regulations Discussed from a Start-Up Perspective”
Presented by: Mr. Oliver Marseille, Founder and CTO of Hemovent
14:30 – 15:00 | Open Questions / Conclusion
MEET OUR SPEAKERS
Adrian Keene: Mr. Keene currently serves as the Director of Product Development Strategy at NAMSA. In this position, he utilizes his broad experience of effectively managing European medical device regulatory requirements to support clients worldwide, and to provide a balanced interpretation of the needs and expectations of competent authorities and manufacturers. Adrian previously held the position of Notified Body Head of SGS (UK), and also served as the Global Clinical Affairs and Regulatory Manager for Medical Devices (SGS) with responsibility for conformity assessment activities for high-risk (class III) devices under the Medical Devices Directive (MDD).
In all, Adrian has 25 years’ experience in the medical device industry with a wide array of medical products, including drug/device combination devices. He attended the School of Pharmacy at the University of London where he conducted postgraduate research in “Retinoid-Induced Skeletal Toxicity.” Mr. Keene also holds a diploma in “Managing Medical Product Innovation” from the Scandinavian International Management Institute.
Oliver Marseille: Dr. Marseille holds a degree in mechanical engineering and a Ph.D. from the RWTH Aachen. He has over 25 years of experience in the medical device industry. Oliver Marseille was one of the founders of Circulite, a team that developed the smallest implantable blood pump in the world. He is currently the founder and CTO of Hemovent, a start-up company developing a new heart-lung support system.