Meeting the HFE Expectations, Regulations and Standards of a Global Marketplace

Michael Wiklund and the Emergo by UL Human Factors Research & Design team will be at the International Symposium on Human Factors and Ergonomics in Health Care holding a live workshop, WKII: Meeting the HFE Expectations, Regulations and Standards of a Global Marketplace, on Sunday, March 26 at 1:30-4:30 p.m. EST.  

This workshop will address the needs of human factors practitioners who seek a deeper understanding of human factors engineering (HFE) requirements upheld in major markets for healthcare technology. These markets include but are not limited to the 27 member nations of the European Union, Australia, Canada, China, Japan, the United Kingdom and the United States. 

The workshop will review the history of how individual nations’ guidances and internationally driven standards have evolved since the late 1990s. For example, attendees will learn that China’s National Medical Products Administration (NMPA) recently published guidelines for applying HFE to medical devices, just as the U.S. Food and Drug Administration (FDA) first wrote its own guidance for the same purpose in the early 2000s. Moreover, attendees will learn the difference between meeting a nation’s particular standard of care for applying HFE and where there is an expectation to meet a national version of the International Electrotechnical Committee’s HFE standard IEC 62366-1.