Our Facilities are ISO 13485 Certified!

Our Facilities are ISO 13485 Certified!

2A70PH7 ISO 13485 stamp sign - medical devices, quality management systems and requirements for regulatory purposes

Today, we are extremely proud to announce that our California locations, which include our laboratory in Concord as well as our production facility in Dixon, have achieved ISO 13485 : 2016 certification. With this new milestone, our facilities that are dedicated to developing and manufacturing photopolymer resins for 3D printing are well-positioned to support medical device manufacturers. By achieving ISO 13485, Loctite 3D Printing can support non-implantable medical devices while ensuring uniformity across the product life cycle which reduces risks for manufacturers.

As part of the certification requirements, both of our facilities have undergone external audits to confirm compliance in areas including design control, process and production control, change management, product traceability and risk management.

“The last thing you want to do with medical applications is cut corners, which is why Henkel took the step to obtain the ISO 13485 certification,” says Rob Clemons, 3D Printing Engineer. “It gives our customers the assurance that our products are designed and manufactured to a high standard, reducing the risk associated with launching a product in the healthcare market.”

Read the full press announcement to learn more about each area of compliance and how technology, including our proprietary intelligence engine, Albert, played a critical role in obtaining the ISO 13485 certification.

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