Earlier this year FDA released the DH Action Plan, initiating several new guidances, policy changes, and its pre-certification program.
Note: Information on the pre-certification program progress during 2017 and release of new guidance (December 2017) is posted separately.
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.
