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!