Day

February 4, 2011
Risk/hazard analysis for medical devices and their software require extensive analysis, documentation, and maintenance of complex information. Creation and maintenance of extensive tables, fault tree, and HAZOP diagrams can seem overwhelming. For complex and high risk systems the information can be voluminous and software tools can be very productive. Trace tools such as DOORS, CALIBER-RM,...
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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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