At the core of BellaSeno’s 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.
BellaSeno’s quality management system (QMS) is certified according to 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 BellaSeno’s custom-built ISO Class 5 cleanroom at its manufacturing facility in Leipzig, Germany.