On December 16, 2025, a proposal for a major update to the Medical Device Regulation was released. While it is not yet in force and is expected to be voted on by Q2 2027, the proposal has foreseeable impacts on ongoing submissions, timelines, and how organizations future proof their MDR strategies.
With a focus on MDR and AI related topics, participants will:
Language: English
Cost: No charge
Cannot make a live session? Register now and receive a complimentary recording after the live event.
Director, Technical Assessment, SGS North America
Kevin Holochwost has worked in the regulatory industry within notified bodies for more than a decade and has over 20 years of experience designing software and hardware systems for medical devices. Earlier in his career, he worked as a physicist and statistician.
Technical Director, Medical Audit, SGS
Balázs Bozsik is the Technical Director for the Medical Audit team at SGS North America. He holds a degree in integrated mechanical engineering from the Budapest University of Technology and Economics. His background includes manufacturing technology and design engineering in medical imaging, automotive, and consumer lighting industries. Prior to joining SGS, he spent over 14 years with another TIC organization, serving as Global MDSAP Program Manager, certification officer, product specialist for active medical devices and medical software, and medical auditor across major certification schemes.
Vice President, Sales, Medical Division, SGS North America
Greg Jacobson is Vice President of Sales for the medical division at SGS North America. He contributes to strategic planning, resource alignment, and sales process improvement to enhance client satisfaction. Greg has extensive experience in medical device certification sales and has managed high risk device accounts for more than a decade, along with holding leadership sales roles both within and outside the TIC industry.
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