💉 Medical Equipment Components

We machine stainless steel 303/304/316L, 17-4PH, titanium Ti-6Al-4V ELI (Grade 23), PEEK (medical grade), Ultem, and aluminum. All materials are supplied with ISO 13485-compliant material certificates. For implantable-grade components, we work exclusively with certified suppliers who maintain full batch traceability.

Our facility operates under ISO 9001:2015 and AS9100D. For ISO 13485-specific medical device production, we partner with certified subcontractors for special processes while performing primary machining in-house. Our quality system includes device history records (DHR), device master records (DMR), and full lot traceability for medical components.

We achieve Ra 0.2µm on cutting and articulating surfaces, and Ra 0.4µm on general instrument surfaces. Electropolishing is available for stainless steel components to achieve medical-grade passivation (ASTM A967). Our finishing processes create surfaces that meet sterilization compatibility requirements.

Yes. For components requiring clean-room assembly, we perform final machining in controlled environments with proper chip and coolant management. Parts are ultrasonically cleaned — including blind holes and internal features — and individually packaged to prevent contamination. Material selection considers autoclave and EtO sterilization compatibility.

We hold ±0.005mm on critical features such as hinge pins, mating diameters, and cutting edges. General dimensions are held to ±0.025mm. All critical dimensions are verified with Zeiss CMM and documented in individual inspection reports. For high-volume medical components, we use SPC with in-process gauging.

We machine micro-scale components in the 1-50mm range using Swiss-type CNC lathes and micro-milling centers. Features as small as 0.3mm diameter holes, 0.1mm wall thicknesses, and M1.0 threads are routine. Our micro-machining capabilities include micro-EDM for holes down to 0.05mm diameter.