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  • Welcome to your QMS
  • Quality Manual
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  • Records
  • TF_Legit.Health_Plus
  • Licenses and accreditations
  • External documentation
    • 01 ES 🇪🇸 regulations
    • 02 US 🇺🇸 CFR FDA
    • 03_Clinical studies
    • 04 EU 🇪🇺 Medical devices
    • 05_GP-004 Vigilance system
      • 05_01_T-004_TREND REPORT_Meddev_2-12_1_Rev8
      • 05_02_T-004_PSR_Meddev_2-12_1_Rev8
      • 05_03_T-004_NCA REPORT_Meddev_2-12_1_Rev8
      • 05_04_T-004_MIR_Meddev_2-12_1_Rev8
      • 05_05_MIR_form_v7.2.1b
      • 05_06_T-004_FSN_Meddev_2-12_1_Rev8
      • 05_07_T-004_FSCA_Meddev_2-12_1_Rev8
    • 06_Machine learning
    • 07 Quality regulations
    • 08 MX 🇲🇽 regulations
    • 09 Pharmacy
    • 10 Other
    • 11 UK 🇬🇧 Medical devices
    • 12 EU 🇪🇺 AI Act
  • External documentation
  • 05_GP-004 Vigilance system
  • 05_02_T-004_PSR_Meddev_2-12_1_Rev8

05_02_T-004_PSR_Meddev_2-12_1_Rev8

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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.)