Notable Changes in the New FDA Draft Guidance – Content of Premarket Submissions for Device Software Functions
[…] of additional consensus standards and guidance documents, including – ANSI/AAMI/IEC 62304: Medical Device Software – Software Life Cycle Processes Off-The-Shelf Software Use in Medical Devices Provision of Examples (Documentation Level, System and Software Architecture Diagram Chart Examples) RELATED: Understanding FDA Medical Device Class and Classifications, and its Impact on Requirements Management Let’s analyze each […]