Protagen receives ISO 13485 certification for medical devices

Protagen, a company developing advanced diagnostic tools to address some of the most severe autoimmune diseases, has received the ISO 13485 certification and now officially complies with the internationally recognised quality standard for medical devices.

The ISO 13485 certification covers the development, production and distribution of in-vitro diagnostics (IVD) for autoimmune diseases. The certificate demonstrates that Protagen has successfully implemented a quality management system that conforms to the worldwide standard for medical device and diagnostic manufacturing.

Stefan Müllner, Protagen CEO, stated: “We have been ISO 9001 certified for some years now. The addition of the new ISO 13485 certification clearly shows our continued commitment to the highest level of quality management and design controls. This guarantees the development and production of safe and effective products and services, and our international customer base can be assured that the products we are delivering are of the highest standards. The ISO 13485 criteria will provide a quality foundation upon which we and our partners will develop new diagnostic products.”

The ISO (International Organisation for Standardisation) is the world‘s largest developer and publisher of International Standards. Receipt of ISO 13485 certification confirms Protagen’s ongoing commitment to meeting the requirements of its customers and regulatory bodies.