At the AAMI/FDA Software Regulatory Class being held this week, it was stated that the following are expected to be released this summer by FDA:
– Revision to the premarket cybersecurity guidance
– Final of the interoperability guidance
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.
