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  • Welcome to your QMS
  • Quality Manual
  • Procedures
    • GP-001 Control of documents
    • GP-002 Quality planning
    • GP-003 Audits
    • GP-004 Vigilance system
    • GP-005 Human Resources and Training
    • GP-006 Non-conformity, Corrective and Preventive actions
    • GP-007 Post-market surveillance
    • GP-008 Product requirements
    • GP-009 Sales
    • GP-010 Purchases and suppliers evaluation
    • GP-011 Provision of service
    • GP-012 Design, redesign and development
    • GP-013 Risk management
    • GP-014 Feedback and complaints
    • GP-015 Clinical evaluation
    • GP-016 Traceability and identification
    • GP-017 Technical assistance service
    • GP-018 Infrastructure and facilities
    • GP-019 Software validation plan
    • GP-020 QMS Data analysis
    • GP-021 Communications
    • GP-022 Document translation
    • GP-023 Change control management
    • GP-024 Predetermined Change Control Plan
    • GP-025 Usability and Human Factors Engineering
    • GP-027 Corporate Governance
    • GP-028 AI Development
      • Specific procedures
        • T-TF-028-001 AI Description
        • T-TF-028-002 AI Development Plan
        • T-TF-028-003 Data Collection Instructions
        • T-TF-028-004 Data Annotation Instructions
        • T-TF-028-005 AI Development Report
        • T-TF-028-006 AI Release Report
        • T-TF-028-007 AI Retraining Report
        • T-TF-028-008 AI Reevaluation Report
        • T-TF-028-009 AI Design Checks
        • T-TF-028-010 AI V&V Checks
        • T-TF-028-011 AI Risk Assessment
    • GP-029 Software Delivery and Commissioning
    • GP-030 Cyber Security Management
    • GP-050 Data Protection
    • GP-051 Security violations
    • GP-052 Data Privacy Impact Assessment (DPIA)
    • GP-100 Business Continuity (BCP) and Disaster Recovery plans (DRP)
    • GP-101 Information security
    • GP-200 Remote Data Acquisition in Clinical Investigations
    • GP-026 Market-specific product requirements
    • GP-110 Esquema Nacional de Seguridad
  • Records
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  • Legit.Health Plus Version 1.1.0.1
  • Legit.Health Utilities
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  • Procedures
  • GP-028 AI Development
  • Specific procedures
  • T-TF-028-002 AI Development Plan

T-TF-028-002 AI Development Plan

Table of contents
  • Abbreviations
  • Introduction
    • Context
    • Objectives
  • Team
  • Project Management
    • Meetings
    • Management Tools
    • Project Planning
  • Environment
    • Development Tools
    • Development Software
    • Development Environment
  • AI Development Plan
    • Development Cycle
    • Development Specifications
    • Development Steps
  • Data Management Plan
    • Good Practices
      • Data Collection & Curation
      • Data Quality & Integrity
      • Ground Truth Determination
      • Sequestration of Test Data
    • Working Plan
  • Training & Evaluation Plan
    • Good Practices
      • Reproducibility and Traceability
      • Model Design & Selection
      • Model Training & Tuning
      • Model Evaluation & Validation
    • Working Plan
  • Release Plan
    • Deliverables
    • Documentation
  • Risk Management Plan
    • AI Risk Identification
    • Risk Assessment
    • Risk Mitigation
  • Related Documents

Abbreviations​

TermDefinition

Introduction​

Context​

Describe the context for this AI development project. Include the device, intended use, and role of AI algorithms.

Objectives​

List the primary objectives of this development plan.

Team​

RoleDescription and ResponsibilitiesPerson(s)

Project Management​

Meetings​

Define the meeting cadence and types (e.g., sprint meetings, daily stand-ups, technical reviews).

Management Tools​

ToolDescription

Project Planning​

Describe the overall project planning approach and timeline.

Environment​

Development Tools​

ToolDescription

Development Software​

SoftwareDescription

Development Environment​

EnvironmentDescription

Minimum Requirements:

  • Requirement 1
  • Requirement 2

AI Development Plan​

Development Cycle​

Describe the development cycle following GP-028 (Design Phase, Development Phase, Verification & Validation Phase).

Development Specifications​

Reference the AI Description document (R-TF-028-001) that governs this development.

Development Steps​

List the high-level development steps.

  1. Data Management
  2. Training & Evaluation
  3. Release (V&V)

Data Management Plan​

Good Practices​

Data Collection & Curation​

Describe data collection and curation practices.

Data Quality & Integrity​

Describe data quality and integrity measures.

Ground Truth Determination​

Describe the methodology for establishing ground truth.

Sequestration of Test Data​

Describe the approach to test data partitioning and sequestration.

Working Plan​

List the data management workflow steps.

  1. Step 1
  2. Step 2

Training & Evaluation Plan​

Good Practices​

Reproducibility and Traceability​

Describe versioning and traceability measures.

Model Design & Selection​

Describe the approach to model architecture selection.

Model Training & Tuning​

Describe training methodology, augmentation, and optimization approaches.

Model Evaluation & Validation​

Describe evaluation metrics, validation strategy, and acceptance criteria.

Working Plan​

List the training and evaluation workflow steps.

  1. Step 1
  2. Step 2

Release Plan​

Deliverables​

List the deliverables for the software integration team.

Documentation​

Describe the documentation to be produced.

Risk Management Plan​

AI Risk Identification​

Describe the approach to identifying AI-specific risks.

Risk Assessment​

Describe the risk assessment methodology.

Risk Mitigation​

Describe the approach to risk mitigation.

Related Documents​

Document IDTitle
R-TF-028-001
R-TF-028-003
R-TF-028-004
R-TF-028-011

Signature meaning

The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:

  • Author: JD-009
  • Reviewer: JD-009
  • Approver: JD-005
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T-TF-028-001 AI Description
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T-TF-028-003 Data Collection Instructions
  • Abbreviations
  • Introduction
    • Context
    • Objectives
  • Team
  • Project Management
    • Meetings
    • Management Tools
    • Project Planning
  • Environment
    • Development Tools
    • Development Software
    • Development Environment
  • AI Development Plan
    • Development Cycle
    • Development Specifications
    • Development Steps
  • Data Management Plan
    • Good Practices
      • Data Collection & Curation
      • Data Quality & Integrity
      • Ground Truth Determination
      • Sequestration of Test Data
    • Working Plan
  • Training & Evaluation Plan
    • Good Practices
      • Reproducibility and Traceability
      • Model Design & Selection
      • Model Training & Tuning
      • Model Evaluation & Validation
    • Working Plan
  • Release Plan
    • Deliverables
    • Documentation
  • Risk Management Plan
    • AI Risk Identification
    • Risk Assessment
    • Risk Mitigation
  • Related Documents
All the information contained in this QMS is confidential. The recipient agrees not to transmit or reproduce the information, neither by himself nor by third parties, through whichever means, without obtaining the prior written permission of Legit.Health (AI Labs Group S.L.)