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Quality

Compliance Standards

  • FDA CFR 21 Part 820quality
    Quality System Regulation – Medical Devices
  • ISO 13485 – 2016 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 13485-2016 Certification Download

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