We are proud to announce that HCM Medical has received by the BSI Notified Body, the official ISO 13485 Certificate.
Receiving this certificate enables us to manufacture our customers product of biological origin; either the processing of animal tissues into new implants as well as the purification of biological materials for the manufacturing of high quality implants.
It is further proof of our unwavering commitment to our customers throughout the world.
ISO 13485 is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry.
We have ISO-5 and ISO-7 cleanrooms in our Nijmegen facilities where we apply different technologies, such as Supercritical-CO2 processing, Freeze drying, Electro Spinning and Aseptic Processing.
This certificate gives us the green light to start manufacturing our customers unique and high-tech medical products.