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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-001-005 List of external documents
        • 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
        • T-001-009 Training on procedures of the QMS
      • 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-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
    • 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
  • Licenses and accreditations
  • Applicable Standards and Regulations
  • Grants
  • Pricing
  • Public tenders
  • Procedures
  • GP-001 Control of documents
  • Templates
  • T-001-006 IFU and label validation YYYY_nnn

T-001-006 IFU and label validation YYYY_nnn

  • Governed by GP-001 Document and Records Control

Medical device​

Product information
Product or trade name
Product version
Basic UDI-DI
EMDN code(s)
Class

Label validation​

RequirementValidationNotes
The name or trade name of the device.⬜️
The name or trade name and address of the manufacturer.⬜️
The details strictly necessary to identify the device and the contents of the packaging.⬜️
The lot number or the serial number of the device.⬜️
The UDI code.⬜️
The special storage and/or handling conditions.⬜️
Any special operating instructions.⬜️
Any warnings and/or precautions to take.⬜️
Manufacture date.⬜️
If the intended purpose of the device is not obvious to the user, it must be clearly stated.⬜️
An indication that the device is a medical device.⬜️

IFU validation​

RequirementValidationNotes
The name or trade name of the device.⬜️
The name or trade name and address of the manufacturer.⬜️
The details strictly necessary to identify the device and the contents of the packaging especially for the users.⬜️
The special storage and/or handling conditions.⬜️
Any special operating instructions.⬜️
Any warnings and/or precautions to take.⬜️
Device's intended purpose with a clear specification of indications, contra-indications, targeted patients and intended users.⬜️
The classification of the device according to the applicable standards.⬜️
Warning for any undesirable side effects.⬜️
All information needed to verify whether the device can operate correctly and safely, with details of the nature and frequency of the maintenance to ensure safety and performance.⬜️
Information regarding the risks of reciprocal interference posed by the presence of the device during specific treatment.⬜️
Any contra-indications or precautions to be taken for the device safety use and performance.⬜️
Date of issue of the instructions for use.⬜️
A notice to the user and/or patient that any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent national authority.⬜️

Other IFU validation activities performed​

note

To include if we have performed any clinical study, PMCF activities, knowledge based on the legacy device...

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-001-005 List of external documents
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T-001-007 Manufacturer declaration of conformity_MDR
  • Medical device
  • Label validation
  • IFU validation
    • Other IFU validation activities performed
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.)