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Communicating About AI – Regulatory Requirements for AI/ML-enabled Medical Devices

  • Presentation
  • Software Documentation
  • 24. April
  • 04:00 PM (CEST) - 04:40 PM (CEST)
  • finished
  • Michael Engler

    Michael Engler

    • EMPIANA GmbH

Contents

Regulators such as FDA and the EU commission mandate information to be communicated to users of AI/ML-enabled medical devices. This includes information about training data, biases, and limitations of the AI/ML-enabled medical devices. Making this information readily accessible in the right context needs the collaboration of technical writers as well as human factors and usability engineers.

The presentation will motivate that communicating the properties and limitations of AI/ML-enabled medical devices is important to understand the benefits and risks of AI/ML-enabled medical devices. Especially, limitations and biases are important for users to understand to avoid patient harm. Furthermore, the presentation will summarize what content the FDA and the EU regulations require us communicate. Finally, we will look through the lens of the user on how the context of use, users’ knowledge and experience as well as the users’ tasks need to be understood to make such communication successful.

Takeaways

- Why should we communicate about AI/ML-enabled medical devices?

- What FDA and EU regulatory requirements do we need communicate?

- How do we optimize communication about AI/ML-enabled medical devices?

Prior knowledge

Experience with medical devices a plus.

Speaker

Michael Engler

Michael Engler

  • EMPIANA GmbH
Biography

Michael Engler is a Senior Consultant and Managing Director at EMPIANA GmbH & Co. KG with a focus on AI, requirements engineering, and usability engineering. With over fifteen years of experience, he advises, trains, and coaches medical device companies. He has held teaching positions at Friedrich-Alexander University Erlangen and the University of Applied Sciences Upper Austria (FH Oberösterreich), where he taught courses on usability engineering for medical devices.

For TÜV Rheinland and TÜV SÜD, Michael conducts seminars on developing medical device software and usability engineering for medical devices. He is involved in the standardization committee DKE/UK 811.4 "Ergonomics, Usability, User Instructions" and the international working group JWG4 focused on IEC 62366-1 (Usability Engineering for Medical Devices).

Michael serves as Chairman of the Medical Technology Working Group at the German Usability Professionals Association.

Previously, he was a Partner and Managing Director at Benkana Interfaces GmbH & Co. KG and a Consultant at Method Park Software AG. He also worked for two years in Ipswich with British Telecom.

Michael Engler holds a diploma in computer science (FH) with a focus on media informatics.

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