What is SaMD – When Software Alone Becomes a Medical Device
What is SaMD – When Software Alone Becomes a Medical Device Smartphone applications support physician diagnoses, and game-like software is […]
SaMD
Software
IEC 62304
Why Verification Records Are Required for All Specifications
Why Verification Records Are Required for All Specifications In the development of medical device software, the IEC 62304 standard requires
IEC 62304
Understanding Software Items – The Rationale Behind Ambiguous Definitions
Understanding Software Items – The Rationale Behind Ambiguous Definitions The Definition of Software Items and the Reasons for Ambiguity To
未分類
Why Software Safety Classes Can Be Reduced Through Other Risk Control Measures
Why Software Safety Classes Can Be Reduced Through Other Risk Control Measures In medical device development, ensuring software safety is
