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