Dispositifs médicaux
Instruments, composants proches de l'implant et matériel de diagnostic
Instruments chirurgicaux, plaques osseuses, piliers dentaires, boîtiers de diagnostic et composants fluidiques en 316L, 17-4PH, Ti-6Al-4V et PEEK — nettoyés, passivés et conditionnés selon votre procédé validé.
Exigences types
- Système qualité aligné ISO 13485
- Lots matière qualité médicale séparés
- Nettoyage et conditionnement validés
- Arêtes maîtrisées et sans bavure
- Maîtrise des modifications avec accord client
Composants usinés
La documentation technique est tenue en anglais afin de préserver la précision des termes d'ingénierie.
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.
Vous travaillez dans ce secteur ?
Nous pouvons partager des références et la documentation qualité sous NDA.
- Revu par un ingénieur méthodes
- NDA possible avant échange de fichiers