Global Medical Device Human Factors, Usability & Safety Summit 2027

Key facts

Date: 25 — 26 February, 2027

Place: Berlin

Conference Overview

The Global Medical Device Human Factors, Usability & Safety Summit is a senior-level gathering for the professionals shaping how medical devices are designed, tested, and approved for safe human use. Human factors testing is no longer just best practice. It is now a regulatory requirement across major jurisdictions across the world. Complication arises when one device has to comply with several national regulations. Additionally, the EU MDR/IVDR framework, IEC 62366-1, and FDA guidance have converged into a compliance environment that demands rigorous, documented evidence of safe usability.

At the same time, the accelerating integration of AI, robotics, and software-as-a-medical-device is introducing entirely new layers of complexity into how devices are designed, tested, and approved; and the community is being asked to keep pace without a settled rulebook.

This summit brings together 80–100 senior professionals from the world’s leading medical device manufacturers, combination product companies, notified bodies, and specialist consultancies to work through these challenges together, built entirely from primary research with the community, not a committee’s best guess.

Navigate Regulatory Convergence: Make sense of EU MDR/IVDR usability requirements, the evolving AI Act, and how IEC 62366-1/-2 requirements are actually being enforced in practice
Close the Documentation Gap: Learn how to conduct and document formative and summative evaluations that hold up under notified body scrutiny
Integrate, Don’t Bolt On: Explore how leading teams are embedding human factors into agile, cross-functional development processes
Manage Risk at Scale: Get practical approaches to use-risk analysis, labelling, and residual risk documentation across large device portfolios
Prepare for What’s Next: Understand how agentic AI and robotics-as-a-service are reshaping human-device interaction, and what that means for your usability engineering file

Hear Directly from Notified Bodies: Engage in candid, closed-door dialogue on documentation expectations and common audit findings

Key topics

Global regulatory alignment: FDA, EU MDR/IEC 62366-2, and China’s NMPA
EU MDR/IVDR usability requirements & the evolving AI Act
Formative and summative evaluation & notified body documentation expectations
Human factors in agile, cross-functional development
Use-risk analysis, labelling & residual risk documentation
Agentic AI and robotics-as-a-service in human-device interaction
The next IEC 62366-2 revision and its impact on usability engineering files
Combination product human factors
Post-market complaint data as a source of HF evidence
Validating usability when AI keeps changing the interface
Building the business case & ROI for human factors investment
Inclusive, multi-population testing and recruitment

Who should attend

Chiefs | Heads of Function | Vice Presidents | Directors | Senior Managers / Engineers specialising in:

Target audience

Medical Device, Pharma & Biotech Companies Human Factors, Safety, UI/UX, Design, Risk Management, Usability, User Insights, Accessibility, Product Development, Regulatory Affairs, Quality Assurance, Labelling

Notified Bodies, European Commission & FDA, Other Regulatory Bodies Auditors, Experts, Advisors, Medical Device Assessment, Usability & Accessibility Experts, Regulatory Affairs Strategy Consultants

Regulatory Consultancies Regulatory Strategy Consultants, Usability & Accessibility Experts

Academic & Research Universities and research centres specialising in human factors, ergonomics, and medical engineering