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.
ISO13485:2016 ISO 13485 Internal Audit(or) Training Course (Live, 3-day)
IEC 62304 and other Emerging Standards Impacting Medical Device Software (Live, 3-day)
Being Agile & Yet CompliantISO 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.
