Regulatory Guidance

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.

Sep 11, 20245 min read

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

Mar 22, 20245 min read

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

Jun 27, 20235 min read

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!