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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 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

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📄️ 02_05_The Q submission program

📄️ 02_06_21 CFR Part 820

📄️ 02_07_Postmarket cybersecurity

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📄️ 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

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📄️ 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

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02_01_Guidance Computer Software Assurance
All the information contained in this QMS is confidential. The recipient agrees not to transmit or reproduce the information, neither by himself nor by third parties, through whichever means, without obtaining the prior written permission of Legit.Health (AI LABS GROUP S.L.)