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