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  • Welcome to your QMS
  • Quality Manual
  • Procedures
  • 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
  • Procedures
  • Records
  • External documentation
  • 05_GP-004 Vigilance system

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

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04_G17_IMDRF Machine learning enabled Medical devices:Key terms and definitions
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05_01_T-004_TREND REPORT_Meddev_2-12_1_Rev8
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