John Murray, FDA’s CDRH Software Compliance Expert gave a presentation on March 15, 2007 entitled: Software Compliance Science. The slides from this are at the link provided. It focuses on the need for critical thinking and articulating what has been done; rather then focusing and templates, forms, and standards.
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.
