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QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
    • GP-001 Control of documents
    • GP-002 Quality planning
      • Templates
        • T-002-001 Quality objectives list
        • T-002-002 Quality objectives
        • T-002-003 Quality indicators
        • T-002-004 Anual management review report
        • T-002-005 Quality Calendar_YYYY_nnn
        • T-002-006 SWOT and CAME analysis
        • T-002-007 Process validation card
        • T-002-009 Regulatory requirements review report
    • 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 Cybersecurity
    • GP-025 Usability and Human Factors Engineering
    • GP-027 Corporate Governance
    • GP-028 AI Development
    • GP-029 Software Delivery And Comissioning
    • 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
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  • Legit.Health Plus Version 1.1.0.0
  • Legit.Health Plus Version 1.1.0.1
  • Licenses and accreditations
  • External documentation
  • Public tenders
  • Procedures
  • GP-002 Quality planning
  • Templates
  • T-002-009 Regulatory requirements review report

T-002-009 Regulatory requirements review report

Purpose​

The purpose of this review is to assess new and modified regulatory requirements applicable to Legit.Health's products and services, ensuring ongoing compliance with ISO 13485 and relevant applicable regulatory standards.

Regulatory requirements reviewed​

List of specific regulatory requirements, including standards, guidelines, laws, etc., that were reviewed during the period

Summary of findings​

Provide a brief description of any new/modified regulatory requirements identified during the review period. Include details such as the source of the requirement, its applicability to the products/services, and any potential impact on current processes or products

Actions plan​

Outline any actions that shall be taken in response to the identified regulatory changes. This may include updates to procedures, revisions to product designs, training of personnel, or other measures to ensure compliance

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-003, JD-004
  • Reviewer: JD-005
  • Approver: JD-001
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T-002-007 Process validation card
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GP-003 Audits
  • Purpose
  • Regulatory requirements reviewed
  • Summary of findings
  • Actions plan
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.)