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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-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
      • Templates
        • T-015-001 Clinical Evaluation Plan_YYYY_nnn
        • T-015-002 Preclinical and clinical evaluation record_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
    • 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 Cybersecurity
    • GP-025 Corporate Governance
    • GP-026 Product requirements for US market
    • GP-027 Product requirements for UK market
    • GP-028 Product requirements for the Brazilian market
    • 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
  • Records
  • TF_Legit.Health_Plus
  • Licenses and accreditations
  • External documentation
  • Procedures
  • GP-015 Clinical evaluation
  • Templates
  • T-015-008 Clinical development plan_YYYY_nnn

T-015-008 Clinical development plan_YYYY_nnn

Clinical development plan​

The following chart shows an overview of the process by which we provide evidence of the performance of our device.

Peer-reviewed publications​

Activity in medical congress​

Clinical trials​

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: Team members involved
  • Reviewer: JD-003, JD-004
  • Approver: JD-001
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T-015-007 Delaration of interest Clinical evaluation team
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T-015-009 Clinical Investigation Plan_Study code_en
  • Clinical development plan
    • Peer-reviewed publications
    • Activity in medical congress
    • Clinical trials
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.)