“BellaSeno is committed to producing sterile absorbable Additive Manufactured devices that exceed its customers’ expectations. This is accomplished by maintaining an effective quality management system and operating in compliance with its rigorous requirements. This commitment is evidenced by the company’s establishment and constant pursuit of total quality objectives.”

BellaSeno’s quality management system (QMS) is certified to the ISO 13485:2016 standard, which is applicable to contract manufacture of additively manufactured implants.

ISO 13485:2016 is the gold standard for medical device companies to ensure the quality, safety and efficacy of products in the medical device field.

Below you will find our ISO 13485:2016 certificate.



Click Here to download our ISO 13485:2016 certificate