The Wyss Center for Bio and Neuroengineering receives ISO 13485 Certification by TÜV SÜD for its Quality Management System

Geneva, Switzerland, October 19 – The Wyss Center for Bio and Neuroengineering, a non-profit research center, announces that it has received ISO 13485:2016 certification for its quality management system (QMS) from TÜV SÜD for the design and the development of standalone software, active and active Implantable Medical Devices. This certification confirms the Wyss Center has developed a state-of-the-art quality management system to underpin its research and development efforts aimed at advancing therapies and treatments for people living with neurological and mental health disorders.

ISO 13485:2016 is the industry standard for QMS systems designed for medical devices. It sets a robust and reproducible framework for the design and development of products that meet customer and regulatory requirements. The International Organization for Standardization (ISO) is a global, independent publisher of standards governing the safety, reliability, and quality of manufactured products. TÜV SÜD is among the most respected and accomplished certification bodies in the market serving thousands of registrations worldwide.

This milestone is a significant achievement for the Wyss Center, reinforcing its mission to translate promising technologies to improve patient care. “Obtaining this certification further supports the Wyss Center’s path to drive technologies and therapies from research into valuable clinical and commercial opportunities that can significantly impact patients’ lives”, said Erwin Böttinger, CEO of the Wyss Center. “We are very proud to receive this ISO 13485 certification, which reflects our organization’s commitment to quality and to meeting international regulatory expectations”.

The ISO 13485:2016 certification affirms the Wyss Center’s robust policies and procedures that are in place to support the design and development of its technologies, such as the ABILITY brain-computer interface (BCI) system. The ABILITY system directly detects brain signals and transmits data wirelessly from the brain to a computer that then enables communication and restoration of movement.

Valentin Beslouin, Quality Assurance Manager at the Wyss Center, commented: “As an organization, we strive to achieve the highest standards in terms of innovation and quality by being compliant to ISO 13485:2016”. Erwin Böttinger, CEO, added that “obtaining this certification is the result of a collective effort by our dedicated multi-disciplinary team.”