FDA AI based SaMD Risk Management
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  • FDA - AI based SaMD Risk Management
  • Level of Concern Document (LCD)
  • Software Description (SDE)
  • AI Expertise (AIE)
  • Device Hazard Analysis (DHA)
  • Software Requirement Specifications (SRS)
  • Training and Test Dataset (TTD)
  • Software Design Specifications (SDS)
  • AI Fairness (AIF)
  • AI Transparency and Explainability (ATE)
  • Traceability Analysis (TRA)
  • Verification and Validation (VAV)
  • Revision Level History (RLH)
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Software Requirement Specifications (SRS)

The Software Requirement Specifications (SRS) document is an important component of the software development process. The SRS is a document that defines the functional and non-functional requirements of the software and provides a clear understanding of what the software should do and how it should perform. Clear requirements specifications of the AI application are set, especially related to the intended purpose, how the AI will be used and associated accountability mechanisms.

Controls related to this risk category are listed as below:

  • SRS 01 - Intended Purpose of AI Use

  • SRS 02 - Accountability Framework

  • SRS 03 - Evaluation of Security

  • SRS 04 - Adversarial Attacks Prevention

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Last updated 2 years ago