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    • 01 ES πŸ‡ͺπŸ‡Έ regulations
    • 02 US πŸ‡ΊπŸ‡Έ CFR FDA
    • 03 Clinical studies
    • 04 EU πŸ‡ͺπŸ‡Ί 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
      • ISO 62366 1_2015_A1_2020
      • ISO 62366-2009
      • ISO 9001_2015
      • deprecated
    • 08 MX πŸ‡²πŸ‡½ regulations
    • 09 Pharmacy
    • 10 Other
    • 11 UK πŸ‡¬πŸ‡§ Medical devices
    • 12 EU πŸ‡ͺπŸ‡Ί AI Act
  • External documentation
  • 07 Quality regulations

07 Quality regulations

πŸ“„οΈ ISO 13485_2016

πŸ“„οΈ ISO 14155 Invest clinica PS - BPC

πŸ“„οΈ ISO 9000_2015 Vocabulary

πŸ“„οΈ ISO 14971-2019

πŸ“„οΈ ISO 15223-1_2016

πŸ“„οΈ ISO 24971

πŸ“„οΈ ISO 27001

πŸ“„οΈ ISO 27002

πŸ“„οΈ IEC 62304

IEC 62304:2006

πŸ“„οΈ ISO 62366 1_2015_A1_2020

πŸ“„οΈ ISO 62366-2009

πŸ“„οΈ ISO 9001_2015

πŸ—ƒοΈ deprecated

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ISO 13485_2016
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