Medical device prototyping requires more than precision machining. Our controlled environment produces FDA-submission ready prototypes with full material certifications (ASTM F136 for titanium, USP Class VI for plastics). For orthopedic implant trials, we deliver CNC-machined cobalt-chrome prototypes with Ra <0.8μm surface finishes and passivation treatments. The service streamlines 510(k) submissions by providing validated sterilization protocols for anodized aluminum housings and laser-cut stainless steel components. A recent collaboration produced functional prototypes of robotic surgical tools with integrated strain gauges, accelerating animal trial approvals by 5 months.
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