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