FDA presentation slides ” Computerized Systems used in clinical trials” given by Stan W. Woollen May 27, 1999 at the ACRP annual meeting. This presentation addressed U.S. FDA 21 CFR Part 11 and the FDA guidance for Computerized Systems used in clinical trials and discussed their interrelationships.
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.
