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  • Welcome to your QMS
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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
      • deprecated
      • EN 82304-1:2017
      • IEC 62304
      • ISO 13485:2016
      • ISO 14155:2020
      • ISO 14971:2019
      • ISO 15223-1:2016
      • ISO 14971
      • ISO 27001:2013
      • ISO 27002:2013
      • ISO 62366-1:2015/A1:2020
      • ISO 62366:2009
      • ISO 9000:2015 Vocabulary
      • ISO 9001:2015
    • 08 MX 🇲🇽 regulations
    • 09 Pharmacy
    • 10 Other
    • 11 UK 🇬🇧 Medical devices
    • 12 Artificial Intelligence Act
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  • 07 Quality regulations
  • ISO 13485:2016

ISO 13485:2016

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IEC 62304
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ISO 14155:2020
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