Day

October 12, 2000
“Your firm failed to adequately validate software integral to the IVD, IVD wireless and … devices as required by 21 CFR 820.75. For example, structural testing of the software is not completed or documented, there are no software validation protocols available, and the compilers were not validated (FDA 483, Item #5).” SoftwareCPR keywords: Product 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.