The link above provides the slides and notes of a presentation made by David Manalan reqarding FDA’s Quality System Inspection Technique. David is an associate of SoftwareCPR and you can reach him at DManalan@softwarecpr.com or 978-266-1220.
The link above provides the slides and notes of a presentation made by David Manalan reqarding FDA’s Quality System Inspection Technique. David is an associate of SoftwareCPR and you can reach him at DManalan@softwarecpr.com or 978-266-1220.
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.