NSF Medical Devices Summit 2026

Overview

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 Opportunities

André 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

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.