Webinar “Medical Device Usability Engineering: From Basic Concepts to Case Analysis”
Connecting regulatory requirements
Join us for our informative webinar on medical device usability engineering for the EU and US markets under IEC 62366-1 and FDA human factors guidance. In this live session, Angela Chen, technical expert and certifier at TÜV Rheinland Shenzhen, will guide you through the fundamentals of usability engineering, regulatory requirements, evaluation methods, and practical project experience.
Why attend?
Usability isn’t just about good design – for medical devices, it’s a regulatory requirement and a key factor in ensuring safe and effective use. Understanding usability engineering can help identify use-related risks, reduce use errors, and support successful market access.
Webinar
Medical Device Usability Engineering: From Basic Concepts to Case Analysis
Date: October 28, 2026
Time: 10:00 to 11:00 a.m. (CET)
Language: English
What you will learn
- Usability engineering fundamentals under IEC 62366-1 and FDA human factors guidance.
- EU and US regulatory requirements and their impact on device design and documentation.
- Usability evaluation and risk management, including the connection to ISO 14971.
- Formative and summative evaluations – from study design to reporting.
- Practical insights from an electrosurgical generator case study, including a use-related finding and its mitigation.
- The usability testing capabilities, accreditations, and specialized testing environments of TÜV Rheinland Shenzhen (TRSZ).
Who should attend
- Regulatory affairs and quality professionals
- R&D and human factors engineers
- Product managers
- Professionals involved in bringing medical devices to market in EU, US, or China
Meet our expert
Angela Chen
Expert and certifier of medical device testing at TÜV Rheinland (Shenzhen) Co., Ltd.
Technical assessor and ETF 17 member of IECEE CB Scheme.
Angela brings over 20 years of extensive experience in safety testing and certification for medical products, measurement, control, laboratory use equipment, and IT/AV equipment. She also has hardware design background as senior design engineer at multinational companies in Singapore.
No time? No problem! By registering for our webinar, you will receive a recording of the event afterwards.
Register now
You will receive confirmation of your registration by e-mail. After the event, we will make the presentation available to you as a download. If you have any questions or require further information, please do not hesitate to contact us in advance.
There are no participation fees for attending the events. All we ask in return for your participation in our webinar is your contact details and your consent to receive regular e-mail updates on TÜV Rheinland products and news. The fields marked with * are required for a region-specific contact person to coordinate discussions. This enables us to process your inquiries quickly and competently.
Webinar “Medical Device Usability Engineering: From Basic Concepts to Case Analysis”
October 28, 2026 at 10 a.m. (CET)
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