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Laurie Reed
Nov 18, 20247 min read
Takeaways from the MassMEDIC Regulatory Roundup Review
Check out Laurie's take-aways from the MassMEDIC Regulatory Roundup Review. A must-read on latest topics for medical device development.
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FDA Draft Guidance on Predetermined Change Control Plans: Implications for Medical Device Manufacturers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.
Beth Loring
Jun 27, 20235 min read
FDA Guidance on the Q-Submission Program
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!
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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