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Quality

Compliance Standards
  • FDA CFR 21 Part 820
    Quality System Regulation – Medical Devices

  • ISO 13485 Medical devices
    Quality management systems — Requirements for regulatory purposes

  • ISO 14971
    Medical devices — Application of risk management to medical devices

  • ISO 14698
    Cleanrooms and associated controlled environments — Biocontamination control

  • ISO 14644-1
    Cleanrooms and associated controlled environments, Certified ISO Class 5 & 7 Cleanrooms

ISO 13485 Certification Download

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