FDA Connected Health

The link provided is to FDA’s relatively new webpage related to connected health, including cybersecurity, Health IT, Mobile Medical Apps (MMA), and wireless medical devices. The MMA page provides lists of examples of types of MMApps and how they are or are not regulated.

https://www.fda.gov/medicaldevices/digitalhealth/

Upcoming Training

Agile Methods for Medical Device and Health IT Software

One day course that expands on the software risk management topics covered in our IEC 62304 and other Emerging Standards for Medical Device and HealthIT Software course. Essentially the same topics are covered but in greater depth with more attention to hands-on analysis of examples.

Email training@softwarecpr.com for more info.

Corporate Office

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