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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
      • Templates
        • T-011-001 Device OAuth Order
        • T-011-003 Acces Key Order
      • Deprecated
    • 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 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-011 Provision of service
  • Templates
  • T-011-001 Device OAuth Order

T-011-001 Device OAuth Order

Purpose​

Medical device manufacturers must comply with certain standards in accordance with medical device regulations. This record, R-011-001 Device OAuth Order, is necessary to fulfil the requirements of ISO 13485:2016, especially those stated in Article 7.5 Production and service provision. Through this record, the manufacturer can ensure that the device is accessed by authorised personnel only. Such authorisation is granted by the representative of the organisation that contracts the service.

Order​

In , on the date (YYYY-MM-DD), I request the creation OAuth credentials to access the medical device manufactured by AI Labs Group SL for the following email addresses under the supervision of the organisation :

Name of person or organisationEmail

I request AI Labs Group SL to reach out via email to the above-mentioned individuals or organisations to provide them with the OAuth credentials to access the device. By doing so, I authorise them to access the device via API Rest under the instructions and the supervision of my organisation.

The email they will receive should contain the following information:

has granted you access to the medical device manufactured by AI Labs Group SL. In this email, you will find the credentials to access the API Rest service.

  • Username: name@companydomain.com
  • Password: **********

The URL for the testing environment is:

The URL for the production environment is:

You will find the API documentation by appending /docs to the URL. Authentication instructions can be found on the main documentation page.

If you have any questions about how to interact with the service, please let us know.

With my signature, I confirm that the above-mentioned individuals or organisations are authorised to access the device under the instructions and supervision of my organisation.

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-011-003 Acces Key Order
  • Purpose
  • Order
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.)