Medical device supply,
ISO-13485-environment ready.
Precision machined components in stainless 316L and titanium, USP Class VI silicone tubing, biocompatible PTFE. Material traceability and documentation packs designed to drop into a regulated supplier file.
Materials, parts, and documentation for regulated environments.
We supply machined parts and materials to medical-device OEMs and subcontractors. Production occurs at our Hebei mills; documentation, traceability, and biocompatibility data are formatted to support an ISO 13485 supplier-file workflow. M&J Silkroad is not itself ISO 13485 certified — please confirm scope at quote stage.
Tolerances to ±0.05 mm. Stainless 316L, titanium grade 2 / grade 5, PEEK, Delrin. Tight-tolerance brackets, housings, manifolds, custom parts.
Platinum-cured silicone tubing (USP Class VI, FDA 21 CFR 177.2600). Biocompatible PTFE in virgin and filled grades. Material data sheets and lot traceability included.
What you get with every medical-supply order.
EN 10204 3.1 mill certificates for metals. Material data sheets and biocompatibility test summaries (USP Class VI) for polymers. Lot and heat number traceability.
CMM-verified dimensional reports. First-article inspection (FAI) on request. Cleanroom packing available for sensitive components.
Documentation formatted for ISO 13485 supplier files. EU 1935/2004 and 10/2011 food-contact certificates where applicable. Confirm scope at quote stage.
Share your drawing or spec.
We reply within 24 hours.
FOB and DDP-landed pricing, material grade, lead time, and MOQ — on a single quote sheet. UK-based point of contact from enquiry through to delivery.