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Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
From the Notified Body perspective, there have been significant challenges with the implementation of the new Medical Device Regulations from the EU, which in turn has caused potentially difficult decisions for medical device manufacturers and the overall impact of those decisions on the EU healthcare system. The EU Medical Device Directives (MDD) expired on 25 May 2021, replaced by the new Medical Device Regulations (MDR). The transition period will remain in effect until 25 May 2024. Still, holders of MDD certificates will need to move to MDR certification as soon as possible, considering the certificate's expiration date, the complexity of the new regulation, and the limited resources of European Notified Bodies.
Our first presentation will discuss the challenges facing the Notified Body system; the potential difficult decisions that medical device manufacturers will make when determining regulatory strategy; the practical reality of either changing notified bodies or working with multiple notified bodies (e.g., in the case of M&A of a startup); and the overall impact to the EU healthcare system.
Our second presentation comes from an Industry perspective. With the lack of guidance surrounding IVDR, it is critical to learn from others within the industry to avoid reinventing the wheel. The second speaker’s organization has been audited to IVDR and recommended for certification with their product submissions in the final stages of approval. As one of the few companies to go through the process, they have offered to share their experience.
This event is brought to you by the RAPS Indiana Chapter to encourage knowledge sharing and community development. RAC holders may claim 1.5 RAC recertification credit.
A live Q&A portion with the speaker will follow the presentation.
Regulatory Affairs, R&D, Engineering, and Quality personnel
Enterprise Member: Free
RAPS Member: Free
Learning Level: Intermediate – attendees should already be familiar with the EU regulations.
Content is Beginner/Intermediate
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Balázs BozsikTechnical Director - MDD/MDR, SGS North America
With a passion for continuous improvement, Mr. Balazs Bozsik is the Technical Director for the medical audit team of SGS North America. Following his graduation as an integrated mechanical engineer from BUTE in Budapest, Hungary, he gained industrial experience in manufacturing technology and design engineering in the medical (X-ray diagnostic devices), automotive, and consumer lighting industries. Prior to joining SGS, he worked for another TIC organization for over 14 years, including his roles as global MDSAP Program Manager, certification officer, product specialist focusing on active medical devices and medical software, as well as a medical auditor for all major certification schemes.
Heidi Strunk, RACSenior Director, Quality and Regulatory Affairs, Hologic
Heidi Strunk is a regulatory and quality professional with extensive experience in the medical device, in vitro diagnostic (IVD) and life sciences industries on a global scale. She brings to the table over thirty years’ experience in FDA-regulated industries, including nineteen years in management. Her breadth of experience spans large companies to hyper-growth start-ups, mergers/acquisitions, and transfer of product lines into and out of the USA.
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