Tag

820.100
29
Dec

Corrective and Preventive Action (CAPA)

December 29, 2021
What is CAPA?   Corrective and Preventive Action (CAPA) is a fundamental quality process for medical device manufacturers including SaMD.  From the regulations it is really not that complicated.   21 CFR 820.100 reads: (a) Each manufacturer shall establish and maintain procedures for implementing corrective and preventive action. The procedures shall include requirements for: (1)...
Read More

Upcoming Public Courses

IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software training course in Boise, Idaho. 3-Day course.

October 13-15, 2026

Limited Early Bird Registration: $995 / person
Non refundable but transferable.

Or just email training@softwarecpr.com for more info.

Corporate Office

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