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QMSQMS
QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
    • GP-001 Control of documents
      • Annex 1 Responsibility matrix
      • Deprecated
      • Templates
        • T-001-001 Control of documents
        • T-001-002 Manufacturer declaration of conformity
        • T-001-003 List of external documents
        • T-001-005 List of applicable standards and regulations
        • T-001-006 IFU and label validation YYYY_nnn
        • T-001-007 Manufacturer declaration of conformity_MDR
        • T-001-008 _Device name_ label YYYY_nnn
      • Specific procedures
    • 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
    • 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-001 Control of documents
  • Templates
  • T-001-005 List of applicable standards and regulations

T-001-005 List of applicable standards and regulations

  • Governed by GP-001 Control of documents

Introduction​

In accordance with Regulation (EU) 2017/745 (MDR), especially Annex II (Technical Documentation), Annex IX (Conformity Assessment), and Article 10(9), the manufacturer must maintain an up-to-date list of all applicable standards, regulations, and guidance documents relevant to the product and the QMS. This list shall be reviewed at least annually during the Management Review (see GP-002 Quality planning) and whenever necessary (e.g., when new or revised standards are published, or regulatory requirements change).

info

This template is used to create records for the list of applicable standards and regulations. For product-specific standards, the record is stored in the Technical File as R-TF-001-005.

Record information​

  • Record name: R-001-005 List of applicable standards and regulations / R-TF-001-005 (for Technical File)
  • Version: YYYY_nnn
  • Review date: YYYY-MM-DD
  • Next scheduled review: YYYY-MM-DD
  • Reviewed by: JD-004
  • Approved by: JD-001

Spanish Regulations​

CodeNameSourceVersionDateCompliance

US Code of Federal Regulations (CFR - Title 21) and HIPAA​

CodeNameSourceVersionDateCompliance

EU Medical Device Regulations and GDPR​

CodeNameSourceVersionDateCompliance

Guides​

EU Guidelines​

CodeNameSourceVersionDateCompliance

US Guidelines​

CodeNameSourceVersionDateCompliance

Clinical Practice Guidelines (EU and US)​

CodeNameSourceVersionDateCompliance

International Standards​

CodeNameSourceVersionDateHarmonized/Recognized (number)Compliance

Review history​

Review dateReviewerChanges madeApproved by

Approval​

RoleNameSignatureDate
Prepared by
Reviewed by
Approved by

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 Design & Development Manager, JD-004 Quality Manager & PRRC
  • Approver: JD-001 General Manager
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T-001-003 List of external documents
Next
T-001-006 IFU and label validation YYYY_nnn
  • Introduction
  • Record information
  • Spanish Regulations
  • US Code of Federal Regulations (CFR - Title 21) and HIPAA
  • EU Medical Device Regulations and GDPR
  • Guides
    • EU Guidelines
    • US Guidelines
    • Clinical Practice Guidelines (EU and US)
  • International Standards
  • Review history
  • Approval
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.)