Check out Laurie's take-aways from the MassMEDIC Regulatory Roundup Review. A must-read on latest topics for medical device development.

Read about the FDA's new guidance, which details how medical device manufacturers can include pre-planned modifications in their submission.

​ Rebecca Lee ​ At the 2024 HFES (International Human Factors Symposium), Laurie and Jan shared key study design considerations for testing

Check out LHF's analysis of the new FDA guidance on the Q-Submission Program! A must-read for anyone interested in interacting with the FDA!

LHF's summary of Edmond Israelski and William Muto's Risk Management in Human Factors book. Learn how to conduct a uFMEA and FTA!

I recently attended a webinar hosted by MedTech Intelligence called “EU MDR Lessons Learned.” The webinar content was presented by three...

Introduction The use of “stand-alone symbols” or symbols without corresponding explanatory text in medical device instructions offers...

A few interesting things I learned from the FDA HFPMET at this year's HFES healthcare symposium.

The good news is that the FDA has published a report on the importance of observational research.

Last week I attended the sixth annual HFES International Symposium on Human Factors and Ergonomics in Health Care in New Orleans, LA,...

In January, 2017 the US FDA published a draft guidance, Comparative Analyses and Related Comparative Use Human Factors Studies for a...