Date & Time
Starts
May 21, 2025 9:00am CEST
Ends
May 23, 2025 5:00pm CEST
Location
Steigenberger Berlin Airport Hotel
Berlin, Germany
Language
English
Meet our experts at the conference
Our experts will discuss how we help manufacturers develop medical devices and combination products that are safer, more intuitive and compliant with human factors (HF) regulatory expectations.
Schedule a meeting and/or stop by to:
Learn how we support human factors engineering (HFE) submissions, including but not limited to FDA, EU NB/EMA, UK MHRA and China NMPA with solid HFE examples.
Discuss your upcoming or in-progress HFE activities
Learn how our global team conducts usability testing across the U.S. EU, Asian and LATAM markets
See how OPUS™, our digital software platform, can streamline your HF documentation and planning effort
Attend our round table
In addition, we will host a round table discussion during the conference at 4:15 p.m. CET on May 21 to discuss with industry leaders how to extend the life cycle or build upon legacy medical devices, particularly from an HF standpoint.
Our round table will include:
- Discussion of what constitutes a legacy medical device and a significant change from an HF perspective.
- Applying the requirements outlined in IEC62366-1:2015 Annex C: Evaluation of User Interface of Unknown Provenance (UOUP) effectively.
- Exploring the role of (HF-focused) post-market surveillance and associated activities.
- Addressing challenges and strategies in justifying (unexpected) HF activity outcomes from a legacy device perspective.
- Sharing insights on the successful integration of HF activities to extend the life cycle of or build upon a legacy device.
Meet our expert
Yvonne Limpens, Managing Human Factors Specialist
Yvonne Limpens is a Managing Human Factors Specialist with Emergo by UL’s Human Factors Research & Design (HFR&D) team based in Utrecht, The Netherlands. She has been with the team since 2013 and has experience delivering HFE services to the medical device and pharmaceutical industries. Yvonne leads and oversees research activities and helps clients develop key HFE documents for their design history files. Furthermore, she advises and trains clients on how to apply HFE during product development to meet regulators' expectations across the globe. Yvonne holds a B.S. in Industrial Design and an M.S. in Human Technology Interaction, both from Eindhoven University of Technology.
Looking forward to seeing you at the European Medical Device Human Factors and Usability Engineering Conference
Email us at Wanling.Xiong@ul.com or Yvonne.Limpens@ul.com to schedule a meeting.
X
Looking forward to seeing you at the European Medical Device Human Factors and Usability Engineering Conference
Please wait…