Software Documents in 510(k) submission (Moderate Level Concern)
Table 3. Documentation Based on Level of Concern (cited from FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices)
For Moderate Level Concern, the following documents need to be provided.
Level of Concern
Software Description
Device Hazard Analysis
Software Requirements Specification (SRS)
Architecture Design Chart
Software Design Specification (SDS)
Traceability Analysis
Software Development Environment Description
Verification and Validation Documentation
Revision Level History
Unresolved Anomalies (Bugs or Defects)
I am not sure how detail of the software related documents should provided. Do we need provide the voltage signals table with the Pin# on the PCB Control board?
Last edited by luloo117117; 5th July 2009 at 07:03 PM.
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