At the core of our business is a comprehensive quality management and control strategy covering all steps from product design to commercial-scale manufacturing. This results in state-of-the art, safe and precise medical products that meet the highest quality standards.

Our quality management system (QMS) is certified according to EU Medical Device Regulation 2017/745 and ISO 13485:2016 standard, which are also applicable to contract manufacturing of additively manufactured implants. ISO 13485:2016 is the gold standard for medical device companies to ensure optimum quality, safety, and efficacy of products in the medical device field.

Manufacturing takes place in our custom-built ISO Class 5 cleanroom at our manufacturing facility in Leipzig, Germany.

ISO 13485:2016 Certificate

MDR (EU) 2017/745 Certificate