At the 2/28/02 ASQ/NEBDG Software Seminar Alan Kusinitz of SoftwareCPR gave a presentation on the highlights of the new FDA General Principles of Software Validation Guidance and AAMI/ANSI SW68. A copy of the slides is at the link provided.
At the 2/28/02 ASQ/NEBDG Software Seminar Alan Kusinitz of SoftwareCPR gave a presentation on the highlights of the new FDA General Principles of Software Validation Guidance and AAMI/ANSI SW68. A copy of the slides is at the link provided.
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.