Expertise in Additive ManufactURING
leading quality and regulatory consultants for 3D printed medical devices
Let us streamline your next project supported by additive manufacturing technology!
Patient-matched Design
Additive manufacturing allows patient-matched and complex designs for increased performance. Several special quality management considerations are necessary for additively manufactured devices.
Post-Processing Steps
Post-processing steps of additively manufactured parts are typically necessary to remove residues, improve surface characteristics, and add colorants.
Regulatory Approval
As with any novel manufacturing process, additive technology requires manufacturers to address regulatory concerns. We specialize in 510(k) premarket notifications for 3D printed medical devices and accessories.
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