Protagen AG Achieves Significant Milestone with ISO 13485 Certification
Wednesday, 24 June 2015
PROTAGEN AG, a company concerned with the development of 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 recognized 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 world-wide 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 Organization for Standardization) 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.
About Protagen – Diagnostics Differentiated
Protagen AG, headquartered in Dortmund, Germany, specializes in the development of novel diagnostic and companion diagnostic tests to provide better and earlier diagnosis of autoimmune diseases.
Protagen uses its proprietary SeroTag® biomarker platform to identify disease specific autoantibodies and is on target to become the leading provider of autoimmune diagnostic products, specifically targeting diseases with an unmet need for effective diagnostics. With pioneering bioscience techniques, extensive scientific expertise and a broad patent portfolio, Protagen works to develop its own diagnostic pipeline and partners with other organizations to develop and implement new companion diagnostic tools for better personalized treatment strategies.
Dr. Stefan Müllner
T +49 231 9742 6300
Dr. Clare Russell
T +44 1223 828200
M +44 7812 343412