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  • Welcome to your QMS
  • Quality Manual
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  • Legit.Health Plus Version 1.1.0.0
    • Index
    • Overview and Device Description
    • Information provided by the Manufacturer
    • Design and Manufacturing Information
    • GSPR
    • Benefit-Risk Analysis and Risk Management
      • R-TF-013-001 Risk management plan
      • R-TF-013-002 Risk management record
      • R-TF-013-003 Risk management report
      • R-TF-013-004 Checklist ISO 14971
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  • Legit.Health Plus Version 1.1.0.0
  • Benefit-Risk Analysis and Risk Management

Benefit-Risk Analysis and Risk Management

📄️ R-TF-013-001 Risk management plan

Scope

📄️ R-TF-013-002 Risk management record

This record is carried out following the procedure GP-013 Risk management and according to R-TF-013-001 Risk management plan, which is also carried out following GP-013. The definition of the risk control options, the risk levels, risk acceptability and everything else, can be found in GP-013 Risk management.

📄️ R-TF-013-003 Risk management report

Intended use and identification of the qualitative and quantitative characteristics

📄️ R-TF-013-004 Checklist ISO 14971

const contentTitle = "R-TF-013-004 Checklist ISO 14971";

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R-TF-013-001 Risk management 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.)