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!

Read about Beth Loring's and Elizabeth Johansen's work on applying human factors engineering methods to design for under-resourced settings.

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

Rise in Telehealth during Covid 19 In the last year and a half, state-mandated travel and operating capacity restrictions have caused a...

At the beginning of September 2020 I attended the online forum “Digital Health and COVID-19: How COVID is Accelerating Home Use Devices”...

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

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