Henkel’s California facilities dedicated to developing and manufacturing resins for 3D printing, have achieved ISO 13485:2016 certification, an international quality standard. In Henkel’s case, it covers the design and manufacturing of biocompatible resins and other materials used to produce non-implantable medical devices.
“3D printing has immense potential with medical devices, but for it to become mainstream, the additive industry must embrace total quality management. Thus, we want to demonstrate to our customers that we are responsible partners,” said Sean Dsilva, Market Strategy Manager, Incubator business at Henkel.
“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.”
Henkel’s 3D printing team began the journey towards ISO 13485 certification early in 2020. At that time global supply chains for medical supplies including Covid test swabs were highly constrained. Working with a consortium of OEM 3D printer manufacturers and others, Henkel helped develop a 3D printing process. Like most other medical devices, consistency and product safety were key factors.
Henkel’s team used many resources to reach certification. Technology played an important role. Henkel’s quality management system (QMS) is used to provide design, process and production controls. Albert, Henkel’s proprietary intelligence engine, provides data generation and batch level traceability for all components, from raw materials to finished parts.
To learn more about how Henkel is serving the healthcare industry, visit www.LoctiteAM.com