Aaron Joseph

What Are Medical Device Design Controls?

Medical device design controls are the regulations that govern the development of medical devices. The FDA established design controls in 1997 because they found that manufacturing controls alone were not sufficient. The FDA recognized that many patient injuries and deaths were the result of medical devices with fundamental design flaws (i.e. no matter how carefully …

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SaMD

Intro to SaMD

SaMD, or Software as a Medical Device, is not just another mobile app.  It is a new category of medical device that has particular regulatory considerations and is at the forefront of some of the most innovative new healthcare technology.