Today, regulators worldwide expect that manufacturers will apply human factors engineering (HFE, which is also called usability engineering) methods and design principles in the normal course of developing a safe and effective medical device. In the medical device industry, documentation demonstrating mitigation of use-risks is required for regulatory approval and the ability to place products on the market.
Join us for this live webinar:
- What: Live Webinar: Human Factors Engineering : New and Renewed Regulatory Expectations
- When: August 18th, 3 PM Singapore time (UTC/GMT + 8)
- Where: Online - registration required
- Register: http://connect.ul.com/HFE-ASEAN-Webinar.html
UL’s webinar on HFE will help audience members make progress on the first couple of tasks: increasing knowledge or HFE and the related regulations and standards.
During this webinar UL HFE experts will:
- Provide an update on FDA’s and IEC’s latest guidance on applying human factors engineering (HFE) to medical devices and combination products.
- Share our understanding and interpretation of FDA’s new and renewed expectations.
Additional HFE program implementation topics to be covered include:
- Common HFE implementation models
- Costs and benefits of HFE
UL’s Jonathan Kendler and Yvonne Limpens will co-present this webinar.
Jonathan Kendler is the Design Director – Human Factors Engineering, UL. He leads the design and evaluation of various medical devices and is the co-author of several Usability Testing of Medical Devices and has also written various articles about user interface design. He is a member of the Human Factors and Ergonomics Society and the Usability Professionals Association.
Yvonne Limpens is a Senior Human Factors Specialist with UL. Yvonne has Product experience in combination products, imaging systems, lab instruments, surgical instruments and more. Her responsibilities include:
HFE project plan development
User interface inspections
Use-related risk analysis
Formative and summative usability testing
To register, fill in the form on the right.