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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
  • Legit.Health Plus Version 1.1.0.0
  • Legit.Health Plus Version 1.1.0.1
  • Legit.Health Utilities
  • Licenses and accreditations
  • Applicable Standards and Regulations
  • Pricing
  • Public tenders
  • Procedures
  • GP-028 AI Development
  • Specific procedures
  • T-TF-028-001 AI Description

T-TF-028-001 AI Description

Table of contents
  • Purpose
  • Scope
  • Algorithm Summary
  • Algorithm Classification
    • Clinical Models
    • Non-Clinical Models
  • Description and Specifications
    • [Algorithm Name]
      • Description
      • Objectives
      • Endpoints and Requirements
      • Data Specifications
      • Integration Requirements
      • Cybersecurity and Transparency
  • References
  • Related Documents

Purpose​

Define the purpose of this AI Description document. Explain that this document specifies the AI algorithms to be developed, their clinical objectives, performance requirements, and data needs.

Scope​

Define the scope of this document. Specify which algorithms and models are covered, what areas are addressed (specifications, performance endpoints, data requirements, risk management links, etc.).

Algorithm Summary​

Provide a high-level summary table of all algorithms covered in this description.

Algorithm NameTypeClinical ObjectiveKey Output
Algorithm 1
Algorithm 2

Algorithm Classification​

Describe the classification scheme used for algorithms (e.g., Clinical Models vs. Non-Clinical Models). Explain the criteria for each category.

Clinical Models​

Define what constitutes a clinical model and list the models in this category.

Non-Clinical Models​

Define what constitutes a non-clinical model and list the models in this category.

Description and Specifications​

For each algorithm, provide detailed specifications following this structure:

[Algorithm Name]​

Model Classification: [Clinical Model / Non-Clinical Model]

Description​

Provide a detailed technical description of the algorithm, including:

  • Mathematical formulation (if applicable)
  • Model architecture overview
  • Key technical characteristics

Objectives​

List the clinical and technical objectives for this algorithm.

Endpoints and Requirements​

Define the performance endpoints and success criteria.

MetricThresholdInterpretation

Requirements:

  • Requirement 1
  • Requirement 2

Data Specifications​

Describe the data requirements for this algorithm:

  • Dataset characteristics
  • Demographic requirements
  • Quality requirements

Integration Requirements​

Describe how this algorithm integrates with the overall system.

Cybersecurity and Transparency​

Describe cybersecurity considerations and transparency requirements.

References​

List all references cited in this document.

  1. Reference 1
  2. Reference 2

Related Documents​

List related QMS documents.

Document IDTitle
R-TF-028-002
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-028-002 AI Development Plan
  • Purpose
  • Scope
  • Algorithm Summary
  • Algorithm Classification
    • Clinical Models
    • Non-Clinical Models
  • Description and Specifications
    • [Algorithm Name]
      • Description
      • Objectives
      • Endpoints and Requirements
      • Data Specifications
      • Integration Requirements
      • Cybersecurity and Transparency
  • References
  • 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.)