In this webinar, the presenters help attendees develop a greater understanding of the decision points they might face when determining the registration route and the scope of HFE activities.
Webinar date
Oct. 24, 2023
Speakers
Janet Zhang, senior regulatory affairs specialist
Yvonne Limpens, managing human factors specialist
The NMPA has released a series of new regulations and related guidelines to assist medical device manufacturers in adapting to the regulatory environment following the evolving regulatory landscape in China since 2021, inclusive of human factors engineering (HFE).
This webinar will help you gain a better understanding of the decision points they might face when determining the registration route and the scope of HFE activities. You will learn the NMPA’s recommendations for submitting information for each category and will share practical information intended to equip manufacturers for future medical device marketing submissions.
About the presenters
Janet Zhang, senior regulatory affairs specialist
Janet Zhang is located in Tianjin, China, and has almost 10 years of specialized experience in Chinese NMPA (formerly CFDA) medical device registrations. She has successfully assisted manufacturers from all over the world with their registration of more than 80 different product types, covering all risk classes.
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 the Netherlands. She has been with the team since 2013 and has experience delivering HFE services to the medical device, and pharmaceutical industries. She 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. She holds a B.S. in Industrial Design and an M.S. in Human Technology Interaction, both from Eindhoven University of Technology (NL).
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