Medical Devices

Medical machining is documentation as much as precision: every 316L instrument body and PEEK component must trace back to certified mill stock through a controlled process, and a missing certificate stalls a regulatory submission. Biocompatibility means material substitutions that other industries shrug off are simply not allowed. Patient-contact surfaces routinely call for Ra 0.4 µm with electropolish or passivation per ASTM standards your quality system cites. And device programs iterate under design control, so the supplier has to deliver fast revisions without losing the paper trail.

ISO 13485

We understand ISO 13485 supply chains: controlled processes, full material traceability and certificates of conformance to feed your QMS.

FDA 21 CFR 820

We support purchasing controls under FDA 21 CFR 820 with documented inspection records and lot-level traceability on every shipment.

ISO 10993

We support ISO 10993 biocompatibility files by machining only certified medical-grade stock with mill certs supplied per lot.

ANVISA RDC 665

For Brazil-bound devices, we understand ANVISA good manufacturing practice expectations and provide the supplier documentation your registration requires.

We understand and support these requirements; certification and documentation scope is confirmed per order.