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  • Welcome to your QMS
  • Quality Manual
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  • Legit.Health Plus Version 1.1.0.1
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  • Applicable Standards and Regulations
    • 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 Artificial Intelligence Act
  • Public tenders
  • Applicable Standards and Regulations
  • 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

📄️ 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

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Real Decreto 311/2022, de 3 de mayo, por el que se regula el Esquema Nacional de Seguridad
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02_01 Guidance Computer Software Assurance
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