Day

October 30, 2020
Understanding OTS and SOUP is very important in every lifecycle stages of medical device and HealthIT software development.  In the late 1990’s, the US FDA first published guidance documentation on the use of Off-The-Shelf (OTS) software in medical devices (or sometimes referred to as “OTSS”).  At that time, OTSS generally accounted for a very small...
Read More

Cybersecurity Review

Our cybersecurity experts can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

Interested in having a conversation?  Email us to arrange a Zoom meeting or call us at +1 781-721-2921.

office@softwarecpr.com

Corporate Office

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