Skip to main content
QMSQMS
QMS
  • 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-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
      • Templates
        • T-015-001 Clinical Evaluation Plan_YYYY_nnn
        • T-015-003 Clinical Evaluation Report_YYYY_nnn
        • T-015-004 Clinical Investigation Plan_Study code
        • T-015-005 Investigator's Brochure_Study code_es
        • T-015-006 Clinical investigation report_Study code_en
        • T-015-006 Clinical investigation report_Study code_es
        • T-015-007 Delaration of interest Clinical evaluation team
        • T-015-008 Clinical development plan_YYYY_nnn
        • T-015-009 Clinical Investigation Plan_Study code_en
        • T-015-010 Annex E ISO 14155
        • T-015-011 State of the Art
    • GP-016 Traceability and identification
    • GP-017 Technical assistance service
    • GP-018 Infrastructure and facilities
    • GP-019 Non-product software validation
    • 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
    • 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-015 Clinical evaluation
  • Templates

Templates

📄️ T-015-001 Clinical Evaluation Plan_YYYY_nnn

Scope

📄️ T-015-003 Clinical Evaluation Report_YYYY_nnn

Scope

📄️ T-015-004 Clinical Investigation Plan_Study code

Objeto

📄️ T-015-005 Investigator's Brochure_Study code_es

Introducción

📄️ T-015-006 Clinical investigation report_Study code_en

Jump to Clinical Performance, Efficacy and Safety.

📄️ T-015-006 Clinical investigation report_Study code_es

Título de la investigación

📄️ T-015-007 Delaration of interest Clinical evaluation team

Declaration of interest

📄️ T-015-008 Clinical development plan_YYYY_nnn

Clinical development plan

📄️ T-015-009 Clinical Investigation Plan_Study code_en

Scope

📄️ T-015-010 Annex E ISO 14155

Scope

📄️ T-015-011 State of the Art

Objectives and Scope

Previous
GP-015 Clinical evaluation
Next
T-015-001 Clinical Evaluation Plan_YYYY_nnn
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.)