FDA New Digital Health Health and SaMD Initiative

Sandy Hedberg of SoftwareCPR suggests those involved in Health IT or Software only medical devices (SaMD) might find the recent comments by FDA commissioner Scott Gotlieb regarding FDA’s move to a new regulatory approach of interest. The link provided is to his blog positng.

Schedule Discussion with John F. Murray, Jr.

John is currently providing telephone and face-to-face meetings to discuss:  Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.

Leave a message and we will contact you to schedule:

Corporate Office

+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TN) and Italy.