Day

October 23, 1998
Review of the _____ which consisted of the software and hardware components necessary to _____ DHRs and maintain them as electronic records, revealed the following:. Changes to processes were not always reviewed and evaluated or revalidated, where appropriate, and documented [21 CFR 820.75(c)], in that the software validation dated _____ was completed for software _____...
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.