08/31/2020 - News en

Hahn-Schickard in Freiburg certified according to medical device standard

The certification body TÜV SÜD Product Service GmbH certifies quality management systems according to EN ISO 13485:2016.

The certification body TÜV SÜD Product Service GmbH certifies that the Hahn-Schickard Institute for Microanalysis Systems in Freiburg has successfully implemented a quality management system in accordance with the requirements of EN ISO 13485:2016, thus fulfilling the legal and normative requirements for the development and manufacture of diagnostics and other medical devices for clinical and point-of-care applications. The standards and regulations ensure the greatest possible safety for users and patients.

In close cooperation with our customers, we work out specifications, optimize assays for microfluidic automation and develop the optimal workflow for the central laboratory, the decentralized diagnostics center or for point-of-care applications. "With this certification, as a development partner we have reached an important milestone on the way not only to develop but also to manufacture medical products with the highest quality requirements," explains Professor Roland Zengerle, member of the Hahn-Schickard Executive Board in Freiburg. "For our medical technology start-up Spindiag, we are manufacturing cartridges for a corona rapid test in multi-shift operation to enable the upcoming market entry of the mobile test platform".