MMApp used with Drugs

Although FDA’s Device Center tends to exempt many Mobile Medical Apps from regualtion FDA’s Drug Center has its own approach. Our current understanding is that mobile apps distributed with drugs are considered part of a combination product in many cases and the Drug Center will review the MMApp information as part of the product approval process.

Upcoming Training

QSS Software Validation
Planned Instructors:  Brian Pate, John Murray
Location: Boston, MA, USA
Dates:  June 2-4, 2020
Registration Link

Receive $300 discount with Premium-Individual subscription purchase (or $333 per person for Premium-Company subscription)! 

Multi-Student Discounts as well!

Email training@softwarecpr.com
to receive discount

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.