Henkel 3D Printing Facilities Receive Medical Device Manufacturing Quality Certification
The certification covers the design and manufacturing of biocompatible resins and other materials used to produce non-implantable medical devices.
Henkel’s Concord laboratory and Dixon production facilities in California, which are dedicated to developing and manufacturing resins for 3D printing, have achieved ISO 13485:2016 certification. ISO 13485 is an international quality standard that enables medical device manufacturers to specify and implement process and production controls, in addition to providing them with documentation and traceability. In Henkel’s case, the certification covers the design and manufacturing of biocompatible resins and other materials used to produce non-implantable medical devices.
“ISO 13485 ensures uniformity in the design, development, production and delivery of medical devices,” said Rob Clemons, 3D printing engineer at Henkel. “The standard doesn’t just provide a system for measurement and tracking, it helps companies reduce their risk by validating that products, and the materials used in making them, are consistent and safe.”