Design

Has your 3D printing quality management system been verified and/or validated?

Laura Turnage2021-09-24T10:45:26-05:00Henkel’s Concord laboratory and Dixon production facilities in California, USA, which are dedicated to developing and manufacturing resins for 3D printing, have achieved ISO 13485:2016 certification.

What range of medical devices or healthcare applications does your material work for?

Laura Turnage2021-09-24T10:41:02-05:00Henkel materials support for Class I and Class II medical devices and healthcare equipment/components that require biocompatibility or safe to touch.

• Prototypes, Development, and non‐patient interaction tools
• Anatomic models for education
• Wearables and Hearing Aids
• External prosthetics and assistive devices
• Dental applications by our partners Keystone Industries
• Surgical planning (anatomic models, surgical guides)

How do I know if a material is biocompatible?

Laura Turnage2021-06-14T05:22:02-05:00Biocompatibility is assessed in the broader context of such factors as the intended use – safe to touch or on body components - location of a device in or on a patient, how manufacturing processes‐‐‐including 3D printing and post‐processing‐‐‐have impacted the chemistry of a material, and how degradation products of that initial material can affect the patient. For our materials, you will find the test results and biocompatibility features in our Technical Data Sheet (TDS).