Day

October 2, 1997
a) Failure to validate finished device testing software, some of which were incorrectly programmed. b) Test software failed to contain a test process/calculation to assure that finished device accuracy specifications were met. e) Failure to establish written and approved manufacturing procedures for finished device test software for MRX multi board and single board devices.
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
Partners located in the US (CA, FL, MA, MN, TX) and Canada.