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.
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
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