Presentation by FDA’s Larry Kessler regarding effort to develop new guidelines for risk based pre-market reviews by FDA’s Office of Science and Technology. A key emphasis is on evaluation and justification of residual risk (what we at SoftwareCPR often refer to as establishing a safety case).
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
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