3D resins compliancy with different FDA and ISO regulations for manufacturing different classes of biomedical devices in applications such as dental, orthodontics, otoplastics, prostheses, implants, etc depends on their tuning and customisation to appropriate printers and postprocessing units with well designed and validated biomedical manufacturing protocols and workflows.
Medical device certifications cannot rely on "raw material certifications" since depending on their overall design, the equipment used, such as the printer and post processing units, their quality and specifications, the chosen printing and postprocessing settings, and the quality control instrumentation and protocols used, compliant resins may fail the different quality and safety testings required for each class of medical device, such as residual monomer content.
3D resins need to be designed and tuned in accordance with appropriate printing and postprocessing units, protocols, and workflows (overall medical device manufacturing quality validation) 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 choose reliable printing and postprocessing units, design and implement appropriate protocols and workflows to manufacture validated biomedical devices compliant and certifiable with the relevant applicable medical device regulations (FDA and ISO, class I, II, III, IV, etc). For more info read:
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