We implement and maintain the highest industry standards throughout design, development and manufacturing.

Our management system fulfills worldwide medical device regulations (incl. 21 CFR 820) and ISO 13485:2016 (EU). For UnovoMed, compliance with these regulations and standards means not only implementing a quality system but also ensuring that quality-oriented thinking is a core component of our corporate philosophy.

As a part of its development services, UnovoMed thoroughly documents every stage of the process in a comprehensive Design History File. The documentation includes everything needed for a regulatory submission and can be made available directly in CTD or STED format. Alternatively, UnovoMed may issue a MAF.

At UnovoMed, a state-of-the-art risk management process accompanies every development activity. Using best practices, we ensure the lowest possible level of risk through a systematic approach comprising all steps and aspects of device handling, design and manufacturing.

For the commercial demand of our customers we manufacture every year hundreds of millions of parts, components, sub-assemblies and finished products that pose many challenges for quality management. This is why specialists in our quality organization focus on issues relating to the maintenance of the highest possible standards.