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 Design Specifications (SDS)

The Software Design Specifications (SDS) is an important component of the SaMD development process as it provides a detailed description of the software's intended design and functionality, which is used to ensure that the software is developed in accordance with the requirements and standards, and that any potential risks associated with the software are identified and mitigated.

Controls related to this risk category are listed as below:

SDS 01 - Evaluation of Resilience
SDS 02 - System Performance
SDS 03 - Measurable Performance Improvements
SDS 04 - Evaluation of AI Privacy Risks
SDS 05 - Data Misuse Prevention
SDS 06 - AI Privacy Preservation
SDS 07 - AI Profiling Individuals

PreviousTraining and Test Dataset (TTD)NextAI Fairness (AIF)

Last updated 2 years ago