Day

April 29, 1997
Walter Graphtek GMBH 4/29/97 Digital electroencephalography devices 1. Failure to assure that specification changes shall be subject to controls as stringent as those applied to the original device, as required by 21 CFR 820.100(a)(2). For example, there are no documented procedures for the initiation, verification, validation, approval, implementation and documentation of device hardware and 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.