ISO 13485 Medical Device Components Manufacturing

We support custom machined metal parts and molded plastic components, including equipment housings, precision mechanical parts, connectors and fluid-handling components. Send your drawings and intended application so our engineers can review the manufacturing requirements.

Our published ISO 13485 certificate covers the production and servicing of hardware and plastic components for medical devices, excluding activities requiring a production license. Please request the current certificate and confirm that its certified entity, site and scope match your project.

Yes. We offer cleanroom injection molding for custom plastic components requiring a controlled manufacturing environment. Share your cleanliness specification, material grade and handling requirements so we can review the production route.

Please contact our team for the applicable cleanroom classification and supporting facility documentation. The required classification, production activities and inspection conditions should be agreed for your project before production.

Achievable tolerances depend on the material, geometry, feature size and inspection method. Send a dimensioned drawing with critical features and GD&T requirements for a part-specific feasibility review and quotation.

Machining options include stainless steel, titanium, aluminum and engineering plastics such as PEEK. Injection molding materials are reviewed by exact resin grade. Medical-grade designation, documentation and application suitability must be specified and confirmed for the individual project.

Yes. We support prototype machining, mold development, sample review and production orders. The process, inspection plan and production quantity are reviewed together to establish a practical manufacturing route.

Please provide STEP or other 3D CAD files, a dimensioned PDF drawing, material grade, required quantities and surface-finish specifications. Include cleanliness, inspection and documentation requirements. An NDA can be arranged before you share sensitive project files.