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  • Welcome to your QMS
  • Quality Manual
  • Procedures
    • GP-001 Control of documents
    • GP-002 Quality planning
    • GP-003 Audits
    • GP-004 Vigilance system
      • Templates
      • Specific procedures
        • SP-004-001 Product withdrawal
    • 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 Corporate Governance
    • 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
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  • Procedures
  • GP-004 Vigilance system
  • Specific procedures
  • SP-004-001 Product withdrawal

SP-004-001 Product withdrawal

Purpose​

This procedure defines the process to withdraw the product from the market.

Scope​

This procedure applies to the medical devices that we manufacture and commercialize.

Definitions and relevant information​

  • AWS: Amazon Web Services

Responsibilities​

JD-001​

  • To approve the withdrawal of the product.

JD-005​

  • To withdraw and to ensure that the product is not accessible for the users.

Inputs​

  • Decision or need to withdraw the product.

Outputs​

  • T-004-001 Withdrawal record

Development​

Scenarios​

As we have defined at the GP-004 Vigilance system procedure, templatehere are two scenarios that may require to carry out the product withdrawal procedure:

  • Yearly programmed simulation (see R-002-005 Quality Calendar), to ensure the procedure is still valid.
  • Identification thay the medical device is not safe for its use.

Procedure​

The process for withdrawing the product from the market must follow these steps:

  • Request from the JD-001 to take the product off the market
  • The JD-005 accesses the production server in AWS.
  • The JD-005 stops the API.
  • The JD-005 tries to make an API call to make sure it is stopped and records the process using the T-004-001 Withdrawal record.

The procedure for withdrawing the product from the market adheres to a sequence of steps, ensuring a smooth and controlled transition:

  • Initiate Withdrawal Request: A formal request must be submitted to the JD-001, signaling the intent to take the product off the market.
  • Access the Production Server: The JD-005 will then access the production server hosted on AWS, leveraging the appropriate protocols and credentials.
  • Halt the API: With careful precision, the JD-005 will deactivate the API, ensuring all connected services are safely disengaged.
  • Verify the Termination: To confirm the successful cessation of the API, the JD-005 will attempt an API call. This deliberate test ensures that the API has indeed been stopped. The entire process is recorded using the T-004-001 Withdrawal template.

Associated documents​

  • GP-004 Vigilance system
  • T-004-001 Withdrawal record
  • R-002-005 Quality Calendar

Document signature meaning​

  • Author: JD-005 Alfonso Medela
  • Review: JD-004 María Diez
  • Approval: JD-001 Andy Aguilar
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GP-005 Human Resources and Training
  • Purpose
  • Scope
  • Definitions and relevant information
  • Responsibilities
    • JD-001
    • JD-005
  • Inputs
  • Outputs
  • Development
    • Scenarios
    • Procedure
  • Associated documents
  • Document signature meaning
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.)