Quality & certifications
Every AUG Medical device is designed, manufactured and tested within a certified quality management system, so clinicians and distributors can trust what they hold.
Medical devices QMS
Quality management system for the design and manufacture of medical devices.
Quality management
Internationally recognised standard for consistent quality management.
European conformity
Declaration of conformity for placing devices on the European market.
US registration
FDA establishment registration for supply into the United States.
EU MDR 2017/745
Compliance with the European Medical Device Regulation for the EU market.
Quality. Defined.
Quality is not a department at AUG Medical, it is how we work. From incoming material inspection to final release, every batch is traceable and every device is tested against defined acceptance criteria. Our processes are audited regularly to keep our ISO 13485 and ISO 9001 certifications current, and our regulatory team maintains the technical documentation needed for EU-MDR (2017/745), CE and FDA market access.
Need a certificate?
Verified partners can request our ISO, EU-MDR, CE and FDA documents through the resource centre. Requests are reviewed and released via the Distributor Portal.