Day

January 8, 1998
No evidence of validation of computer system or software; use of unrecognized testing methods for testing and release of finished products; and no review and approval by the Quality Control Unit of Oxygen USP and Nitrogen NF. 1. No documented evidence of the validation for the computer system or associated software that is responsible for...
Read More

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

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.