Parts your regulatory affairs team will actually approve.

We operate under ISO 13485-aligned workflows including design controls, document control, non-conforming product handling, and CAPA procedures, but the formal ISO 13485 certificate is pending audit. For customers requiring certified suppliers, we partner with ISO 13485 certified subcontractors on specific project scopes. ISO 9001:2015 formally certified.

Metals: Ti-6Al-4V (Grade 5, Grade 23 ELI), 316L stainless steel, CoCrMo (cobalt chrome), Nitinol (shape memory). Polymers: PEEK (USP Class VI), PEEK-CFR (carbon reinforced), Ultem 1010 (USP Class VI), Radel (PPSU), medical-grade silicone, implantable PLA/PGA. Resins: Formlabs BioMed Clear (USP Class VI), Dental LT Clear (Class IIa).

Yes. We review and sign customer Quality Agreements (QAs), Supplier Quality Agreements (SQAs), and Product-Specific Quality Requirements. Typical review cycle 5–10 business days through our QA department. Our standard medical QA template is available on request.

Final cleaning, packaging and inspection of medical parts can be performed in our ISO 8 (Class 100,000) clean area. For more stringent environments (ISO 7 / Class 10,000 or better), we partner with certified medical contract manufacturers for the terminal cleaning and packaging steps.

316L passivation per ASTM A967, citric or nitric acid protocols, verified by copper sulfate test. Electropolishing for implantable stainless and Nitinol. Titanium anodizing (Type II decorative, Type III wear-resistant) — anodized colors for surgical instrument color coding. Glass bead blast for matte medical cosmetic. Ultrasonic cleaning, IPA rinse, HEPA-filtered drying.

Yes, for trial and development builds. Ti-6Al-4V ELI and PEEK implant prototypes are a regular workstream. For commercially distributed implants requiring regulatory-cleared suppliers, we work alongside customer-nominated sterilization and final-packaging partners. We do not perform terminal sterilization in-house.

Materials we work with carry standard biocompatibility qualifications. PEEK, Ultem 1010, BioMed Clear resin: USP Class VI tested. Ti Grade 23, CoCr: ISO 10993-5 cytotoxicity and ISO 10993-10 sensitization verified by mill. Final device biocompatibility testing remains the customer's responsibility per ISO 10993 series.