Regulatory Affairs NSF Medical Devices Summit 2026

Through expert presentations, industry perspectives, and peer discussion, the program examines topics including FDA inspections after QSIT, international market expansion, software and AI supplier management, U.S. submission readiness, platform technologies, and the future IEC 60601/80601 standards landscape.

Hear perspectives from NSF alongside speakers from Olympus, B. Braun, Ypsomed, Karl Storz, and Siemens Healthineers as they discuss FDA inspection expectations, international market opportunities, software and AI supplier management, U.S. submissions, product development, and emerging standards.
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A Day Built Around Real Industry Challenges

The 2026 program combines regulatory expertise, manufacturer experience, and standards leadership across a range of topics affecting medical device organizations today.

Sessions explore how manufacturers are responding to changing FDA inspection expectations, evaluating opportunities beyond established markets, managing software and AI suppliers, preparing products for U.S. submission, and planning for future developments in the IEC 60601/80601 standards series.

Industry speakers will also share lessons learned from expanding into international markets and managing the realities of implementation once strategic decisions have been made.

The goal is not simply to present regulatory updates, but to provide context, experience, and practical perspectives that help attendees better understand the challenges facing the industry.

Who Should Attend

Medical device professionals across regulatory, quality, clinical, R&D, and manufacturing functions managing compliance and development.

Why Attend

Delegates will gain practical insight into how MedTech organizations are responding to regulatory, technological, and operational changes across global markets. The summit provides a focused forum for understanding current expectations, learning from industry experience, and identifying practical approaches that support clearer planning, stronger decision-making, and more effective implementation.