Dispositivi medicali

Machining for a regulated supply chain

Medical work is judged on consistency and documentation as much as on the part. Our medical routing runs on segregated material lots, dedicated tooling for implant-adjacent components, and a change-control procedure that prevents any silent process modification.

Materials and finishes

316L and 316LVM, 17-4PH, 465 stainless, Ti-6Al-4V ELI (Grade 23), cobalt chrome, PEEK-OPTIMA-grade polymer and Ultem. Surface treatment includes passivation to ASTM A967 or AMS 2700, electropolishing to ASTM B912, and bead blasting with medical-grade media.

Cleanliness and packing

Parts are cleaned in a multi-stage ultrasonic line with deionised water rinse and dried in filtered air. Packing options run from double-bagged cleanroom poly to customer-specified trays and labelling. Particulate and residue testing is available on request.

Surface integrity on instruments

Where an instrument contacts tissue, edge quality matters as much as dimension. We control burr, edge break and Ra on every functional surface and report them — a 0.05 mm burr that a general engineering shop would pass is a rejection in this sector.

Documentation

Certificates of conformity, material certificates, dimensional reports, passivation and cleaning records, and — where you operate under ISO 13485 — the process validation support your notified body will ask for.