Our biocompatible 3D resins are compliant with different FDA and ISO regulations for manufacturing different classes of biomedical devices.

Compliancy to specific biomedical device applications (dental, orthodontics, otoplastics, implants, etc) depends on the specific resin and on its tuning and customisation to appropriate printers, printing and postprocessing setups.  

We can consult you to get the Certification that you need, especially now with the incoming changes in the FDA and ISO, related to the manufacturing of medical devices.

We can design customised safe resins and the safest workflows and protocols to ensure fully compliance with the different certification requirements of your chosen specific biomedical device.

3D resins need to be designed and tuned in accordance with appropriate printing and postprocessing units, protocols, and workflows for achieving maximum biocompatibility:

3Dresyns offers consulting services to help biomedical device manufacturers to design and implement appropriate protocols and workflows to manufacture biomedical devices compliant with the relevant applicable regulations (FDA and ISO, class I, II, III, IV, etc). For more info read:

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