FDA Software Premarket Submissions

This topic contains a number of FDA guidances and SoftwareCPR training aides related to preparation of software information in premarket submissions for FDA including 510(k)s, PMAs, and IDEs.

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
Partners located in the US (CA, FL, MA, MN) and Italy.