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Laurie Reed
Sep 11, 20245 min read
FDA Draft Guidance on Predetermined Change Control Plans: Implications for Medical Device Manufacturers
Read about the FDA's new guidance, which details how medical device manufacturers can include pre-planned modifications in their submission.
Laurie Reed
Mar 22, 20245 min read
Conducting an Aseptic Presentation Study
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Rebecca Lee
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At the 2024 HFES (International Human Factors Symposium), Laurie and Jan shared key study design considerations for testing
Beth Loring
May 7, 20232 min read
A Summary of Risk Management Tools for Human Factors
LHF's summary of Edmond Israelski and William Muto's Risk Management in Human Factors book. Learn how to conduct a uFMEA and FTA!
Beth Loring
Apr 6, 20232 min read
FYI, Most Medical Devices Are Not Designed For Most People
Read about Beth Loring's and Elizabeth Johansen's work on applying human factors engineering methods to design for under-resourced settings.
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