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.
3D resins need to be designed and tuned in accordance with appropriate printing and postprocessing units, protocols, and workflows for achieving maximum biocompatibility:
- About the importance of tuning 3D resins in accordance with appropriate printing and postprocessing units/protocols for 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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