"The benefits outweigh the risk" is a frequently used justification by medical and combination device manufacturers to bring new devices to the market. However, is this justification good enough? Human Factors (HF) professionals, Beth Loring and Hollie Johnston, weigh in on the value of going above and beyond the minimum regulatory requirements to develop devices that are not just safe, but also successful and delightful to use.

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.

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!