ISO 13485 Audited Manufacturing
ISO 13485 is the internationally recognised standard for quality management systems in medical device design and manufacture. Certification by BSI confirms our manufacturer operates under audited processes covering design controls, risk management, production, and post-market surveillance.
- BSI Certificate MD 788664
- Audited design controls and risk management
- Post-market surveillance under controlled processes
Full documentation available on request. Contact support@revogenlab.com.
