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QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
  • Records
  • TF_Legit.Health_Plus
  • Licenses and accreditations
  • External documentation
    • 01 ES 🇪🇸 regulations
    • 02 US 🇺🇸 CFR FDA
      • 02_01_Guidance Computer Software Assurance
      • 02_02_Guidance 21 CFR part 11
      • 02_03_21 CFR Part 11
      • 02_04 General Principles of Software Validation
      • 02_05_The Q submission program
      • 02_06_21 CFR Part 820
      • 02_07_Postmarket cybersecurity
      • 02_08_Marketing Submission Recommendations for a Predetermined Change Control Plan for AI/ML-Enabled Device Software Functions
      • 02_09_Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions
      • 02_10_Applying Human Factors and Usability Engineering to Medical Devices
      • 02_11_Content of Human Factors Information in Medical Device Marketing Submissions
      • 02_12_Content of Premarket Submissions for Device Software Functions
      • 02_13_Small Business Qualification Certification Guidance
    • 03_Clinical studies
    • 04 EU 🇪🇺 Medical devices
    • 05_GP-004 Vigilance system
    • 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
  • 02 US 🇺🇸 CFR FDA
  • 02_01_Guidance Computer Software Assurance

02_01_Guidance Computer Software Assurance

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02 US 🇺🇸 CFR FDA
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02_02_Guidance 21 CFR part 11
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