21 CFR Part 11 Selected References

This topic contains selected references for electronic records and signatures compliance. It is NOT an exhaustive set and MORE can be found by searching the document library on this website. Paid subscribers have access to all items listed while others have limited access. Other training aides may be provided to paid subscribers on request if they can not find what they are looking for on the site and if we have them available.

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.