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Meeting Global Regulations and Expectations for HFE

Gain a deeper understanding of HFE requirements upheld in major markets for healthcare technology, including the 27 member nations of the EU, Australia, Canada, China, Japan, the U.K. and the USA.

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Watch now: Meeting global regulations and expectations for HFE

Watch this webinar to learn about different regions’ human factors engineering (HFE) guidance and internationally driven standards, including a brief history of the evolution of standards.

Webinar date

June 22, 2023


Jenny Collinson, research director (HFR&D), Emergo by UL
Merrick Kossack, research director (HFR&D), Emergo by UL
Frauke Schuurkamp, managing human factors specialist (HFR&D), Emergo by UL


This webinar will help you gain a better understanding of how to apply HFE when developing medical devices for specific markets and in which situations manufacturers can apply HFE more versus less rigorously, depending on regulators’ expectations.

Learning objectives
  • History of HFE guidance and standards development in the medical device industry
  • Basic elements of an HFE program that will satisfy global expectations
  • Discover the benefits of investing in HFE to improve your product’s usability and use safety
  • Specific HFE requirements upheld by certain countries
  • Steps to build an all-purpose HFE program



Jenny Collinson, research director (HFR&D)
Jenny is a research director with Emergo by UL’s Human Factors Research & Design team. Her deep medical device industry experience includes more than 15 years in both product development and HFE roles. She completed a master’s degree in applied ergonomics from the University of Nottingham. She has experience in building HFE processes, integrating them into research and development activities, and creating robust HFE strategies, validation plans and documentation that meet the requirements of regulatory bodies.

Merrick Kossack, research director (HFR&D) 
Merrick’s areas of expertise include integrating HFE into established design and development processes, conducting complex usability studies and advising on human factors strategy to satisfy regulatory needs, particularly for complex systems. He earned a master’s degree in human-machine systems research from the Georgia Institute of Technology and a bachelor’s degree in industrial engineering from the University of Illinois. Kossack is a contributing author to “Applied Human Factors in Medical Device Design” (2019) and an active member of the Association for the Advancement of Medical Instrumentation (AAMI) Human Factors Engineering subcommittee and IEC TC 62/SC 62A/JWG 4. He is also a member of the AAMI faculty staff teaching their Human Factors for Medical Devices course.

Frauke Schuurkamp, managing human factors specialist (HFR&D)
Frauke Schuurkamp has been with the Human Factors Research & Design team since 2013 and leads and oversees research activities such as user research and usability testing. Furthermore, she helps customers develop key HFE documents for their design history files, including use-related risk analyses, and advises customers on how to strategically apply HFE during product development to meet regulators’ expectations. She holds a bachelor’s degree in applied psychology and a master’s in human factors and media psychology. Over the course of her career, she has gained extensive experience in conducting usability tests, developing key HFE documents for regulators and guiding manufacturers in their investments in HFE activities.

Explore our human factors software platform, OPUS™

OPUS offers a wide variety of training, tools, templates and regulatory guidance to help you stay ahead in your HFE activities.

Learn more

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