Glossary of Terms
Human Factors
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About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs

Prior to joining Proxima, Isabella served as the Senior Regulatory & Quality Manager at a medical device company, where she outlined the regulatory strategy & put together design controls & design history documentation. She was the Dir. of CMC & Quality at a biopharmaceutical company, where she oversaw all manufacturing and analytical processes and timelines and ensured CMC regulatory strategy was sufficient for filings in Europe and the US.

The term is considered to be synonymous with “human factors engineering” (HFE) and “usability engineering” (UE). HFE is defined as the application of knowledge about human behaviour, abilities, limitations, and other characteristics of medical device users to the design of medical devices including mechanical and software driven user interfaces, systems, task, user documentation and user training to enhance and demonstrate safe and effective use. The advantages of optimising device deign through application of HFE/UE during the development of medical device reduces the need for design modifications and costly updates after market introduction and offers competitive advantages. In addition, when HFE/UE approaches are adopted during the design development process, the overall ease of use and appeal of a MD can be simultaneously enhanced. FDA has specified guidelines to support industry and manufacturers in improving the design of new medical devices to minimise potential use errors and resulting harms, and reduce risks associated with medical device use.

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