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  • Quality Manual
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    • 01 ES 🇪🇸 regulations
    • 02 US 🇺🇸 CFR FDA
    • 03_Clinical studies
    • 04 EU 🇪🇺 Medical devices
    • 05_GP-004 Vigilance system
    • 06_Machine learning
    • 07 Quality regulations
      • ISO 13485_2016
      • ISO 14155 Invest clinica PS - BPC
      • ISO 9000_2015 Vocabulary
      • ISO 14971-2019
      • ISO 15223-1_2016
      • ISO 24971
      • ISO 27001
      • ISO 27002
      • IEC 62304:2006/A1:2015
      • ISO 62366 1_2015_A1_2020
      • ISO 62366-2009
      • ISO 9001_2015
      • deprecated
    • 08 MX 🇲🇽 regulations
    • 09 Pharmacy
    • 10 Other
    • 11 UK 🇬🇧 Medical devices
    • 12 EU 🇪🇺 AI Act
  • External documentation
  • 07 Quality regulations

07 Quality regulations

📄️ ISO 13485_2016

📄️ ISO 14155 Invest clinica PS - BPC

📄️ ISO 9000_2015 Vocabulary

📄️ ISO 14971-2019

📄️ ISO 15223-1_2016

📄️ ISO 24971

📄️ ISO 27001

📄️ ISO 27002

📄️ IEC 62304:2006/A1:2015

📄️ ISO 62366 1_2015_A1_2020

📄️ ISO 62366-2009

📄️ ISO 9001_2015

🗃️ deprecated

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ISO 13485_2016
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