NSF Medical Devices Summit 2026
NSF Medical Devices Summit 2026 will take place on 12 November 2026 at Saalhaus in Hamburg.
This one-day event brings together medical device manufacturers, regulatory and quality leaders,technical experts, and industry speakers to discuss the pressures shaping global MedTech.The program will focus on practical challenges across international market access, FDA inspection expectations, U.S. submission readiness, software and AI supplier management, platform technologies, and the future IEC 60601/80601 standards landscape.
Through expert presentations, industry case examples, and peer exchange, the summit will examine how manufacturers can respond to regulatory, technological, and operational change in a structured, practical way.
Program Focus
Attendees will hear from NSF subject matter experts and invited industry speakers from OLYMPUS, B. BRAUN, YPSOMED, KARL STORZ, and SIEMENS HEALTHINEERS. The timed agenda will be announced soon.
Confirmed session topics include:
From Local Success to Global Potential: Recognizing International Market OpportunitiesAndré von Malotki, NSF and Katharina Stumborg, OLYMPUS
How manufacturers can assess opportunities beyond the EU and U.S., prioritize expansion, and manage country-specific regulatory requirements, geopolitical factors, import restrictions, sanctions, trade policy changes, and local stakeholder networks.
FDA Foreign Inspections After QSIT: What Has Really Changed?
Julian Thorns, NSF
How FDA inspection behavior is changing following the phase-out of QSIT, with focus on patient safety, real-world device performance, third-party involvement, management reviews, internal audits, documentation, risk-based thinking, and the transition from QSR to the QMSR.
From Expectations to Implementation: A Structured Approach to Supplier Management for Software and AI
Lukas Block, NSF
How manufacturers can translate software and AI supplier expectations into requirements, action items, implementation decisions, and traceable supplier-management controls.
Preparing Established Products for U.S. Submission: How to Prioritize Gaps and Minimize Risks
Eljar Amini-Nejad, NSF and Christoph Erlen, B. BRAUN
Practical methods to identify regulatory and compliance gaps, prioritize remediation, reduce market-entry risk, streamline submission pathways, and strengthen U.S. submission readiness.
Leveraging Platform Technologies for Product Development
Karolina Snajdarova, YPSOMED and Sandra Schaerer, YPSOMED
How platform-based self-injection systems and integrated development support can help manage regulatory and development complexity for drug-device combination products.
The Future IEC 60601/80601 Series: Current Status, Structural Changes and Outlook
Regina Geierhöfer, IEC TC62 Secretary / SIEMENS HEALTHINEERS
An update on the IEC 60601/80601 revision work, expected structural changes, publication timelines, and implications for manufacturers, regulatory affairs teams, test laboratories, and conformity assessment.
Speakers Include
- Katharina Stumborg, OLYMPUS
- André von Malotki, NSF
- Christoph Erlen, B. BRAUN
- Eljar Amini-Nejad, NSF
- Karolina Snajdarova, YPSOMED
- Lukas Block, NSF
- Sandra Schaerer, YPSOMED
- Julian Thorns, NSF
- Karim Djamshidi Gilani, KARL STORZ
- Regina Geierhöfer, IEC TC62 Secretary / SIEMENS HEALTHINEERS
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.
Registration
Registration is now open.
Reserve your place to join medical device quality, regulatory, and technical professionals for a full day of practical insight, discussion, and networking in Hamburg.
Early bird pricing is available through 15 July 2026.
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