FDA - AI based SaMD
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  • FDA - AI based SaMD
  • Data Governance (DG)
    • DG01 - Define Sets
    • DG02 - Dataset Governance Policies
    • DG03 - Dataset Design Choices
    • DG04 - Dataset Source Information
    • DG05 - Dataset Annotations Information
    • DG06 - Dataset Labels Information
    • DG07 - Dataset Cleaning
    • DG08 - Dataset Enrichment
    • DG09 - Dataset Aggregation
    • DG10 - Dataset Description, Assumptions and Purpose
    • DG11 - Dataset Transformation Rationale
    • DG12 - Dataset Bias Identification
    • DG13 - Dataset Bias Mitigation
    • DG14 - Dataset Bias Analysis Action and Assessment
    • DG15 - Dataset Gaps and Shortcomings
    • DG16 - Dataset Bias Monitoring - Ongoing
    • DG17 - Dataset Bias Special/Protected Categories
  • Technical Documentation (TD)
    • TD01 - Technical Documentation Generated
    • TD02 - Additional Technical Documentation
    • TD03 - Technical Details
    • TD04 - Development steps and methods
    • TD05 - Pre-trained or Third party tools/systems
    • TD06 - Design specification
    • TD07 - System Architecture
    • TD08 - Computational Resources
    • TD09 - Data Requirements
    • TD10 - Human Oversight Assessment
    • TD11 - Pre Determined Changes
    • TD12 - Continuous Compliance
    • TD13 - Validation and Testing
    • TD14 - Monitoring, Function and Control
    • TD15 - Risk Management System
    • TD16 - Changes
    • TD17 - Other Technical Standards
    • TD18 - Ongoing Monitoring System
    • TD19 - Reports Signed
  • Transparency and Provision of Information to Users (TPI)
    • TPI01 - Transparency of the AI System
    • TPI02 - Instructions for Use
  • Human Oversight (HO)
    • HO01 - Human Oversight Mechanism
    • HO02 - Human Oversight Details
    • HO03 - Human Oversight - Biometric Identification Systems
  • Accuracy, Robustness and Cybersecurity (ARC)
    • ARC01 - Accuracy Levels
    • ARC02 - Robustness Assessment
    • ARC03 - Continuous Learning Feedback Loop Assessment
    • ARC04 - Cyber Security Assessment
  • Managing SaMD Lifecycle Support Process - Record Keeping (RK)
    • RK01 - Logging Capabilities
    • RK02 - Logging Traceability
    • RK03 - Logging - Situations that May Cause AI Risk
    • RK04 - Logging - Biometric systems requirements
    • RK05 - Details of Off-the-Shelf Components
    • RK06 - Evaluation Process of Off-the-Shelf Components
    • RK07 - Quality Control Process of Off-the-Shelf Components
    • RK08 - Internal Audit Reports
  • Risk Management System (RMS)
    • RMS01 - Risk Management System in Place
    • RMS02 - Risk Management System Capabilities and Processes
    • RMS03 - Risk Management Measures
    • RMS04 - Testing
    • RMS05 - Residual Risks
    • RMS06 - Full Track of Mitigation Measures
  • Quality Management Principles (QMP)
    • QMP01 - Quality Management System in Place
    • QMP02 - Compliance Strategy stated
    • QMP03 - Design processes
    • QMP04 - Development and QA (Quality Assurance) processes
    • QMP05 - Test and Validation Procedures
    • QMP06 - Technical Standards
    • QMP07 - Data Management Procedures
    • QMP08 - Risk Management System
    • QMP09 - Ongoing Monitoring System
    • QMP10 - Incident Reporting Procedures
    • QMP11 - Communications with Competent Authorities
    • QMP12 - Record Keeping Procedures
    • QMP13 - Resource Management Procedures
    • QMP14 - Accountability Framework
  • Post Market Monitoring System (PMS)
    • PMS01 - Post Market Monitoring System in Place
    • PMS02 - Data Collection Assessment
    • PMS03 - Post Market Monitoring Plan
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  1. Post Market Monitoring System (PMS)

PMS02 - Data Collection Assessment

The post-market monitoring system shall actively and systematically collect, document and analyse relevant data provided by users or collected. Other sources on the performance of an AI application throughout their lifetime and allow the provider to evaluate the continuous compliance of AI systems with the OECD AI Principles. Detail or upload a document detailing the data collection and analysis enabled by the post-market monitoring system. Also include an assessment of the extent to which it allows the organisation to evaluate the continuous AI systems for Canada-AIDA.

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Last updated 2 years ago