Day

March 25, 2003
Company: Advanced Radiation Measurements Inc.Product: Radiation beam scanners Date: 3/25/03 Your firm failed to validate processes whose results cannot be fully verified by subsequent inspection and test according to established procedures as required by 21 CFR 820.75. Structural testing conducted as part of your firm’s software validation, and software validation of the Scan Test used...
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.