Quality

Producing products with increasingly stringent permits, is a specialty that is pursued by more and more organizations. It is also for organizations that develop new products, more difficult and costly to convert these products to regular production processes in accordance with the applicable guidelines. HCM Medical specializes in operating the manufacturing as well as all associated quality aspects.

HCM Medical has a BSI certification for ISO 13485:2016 , a WVKL recognition as a tissue establishment, a GMP Certificate for Human Investigational Medicinal Products and a NVWA recognition for the manufacturing of medical devices from category 3-material according to Article 23 of Regulation (EC) no. 1069/2009.