Industry

CNC Machining for
Medical Devices

ISO 13485-Compliant Machining for Life-Critical Parts

ISO 9001:2015ISO 13485 audit-readyRoHS CompliantREACH CompliantFDA 21 CFR Part 820 documentation

In medical device manufacturing, a surface finish that is 0.2 Ra instead of 0.4 Ra, or a bore that is 5 microns oversize, can mean the difference between a cleared device and a failed FDA submission. OrangeSea CNC applies the same disciplined metrology and document control to medical components that we bring to aerospace work. Our facility is ISO 9001:2015 certified and our quality management system is structured to support ISO 13485 customer audits — we welcome engineering teams and quality managers on-site.

Why OrangeSea CNC

What We Bring to Medical Devices

Biocompatible Material Expertise

We machine medical-grade titanium (ASTM F136), 316L stainless, PEEK, Delrin, and polycarbonate daily. Material certificates and biocompatibility data sheets supplied with every order.

Mirror Surface Finishes

Surgical instrument components and implant surfaces machined to Ra 0.2 µm and better. We use diamond tooling and precision grinding where surface integrity is non-negotiable.

Full Document Control

Lot-level traceability, First Article Inspection (FAI) reports, CMM dimensional reports, material certs, and Certificate of Conformance (CoC) issued with every medical order.

Burr-Free Finishing

Medical parts require zero burrs. Our post-machining deburring and edge-break processes are documented in your job traveller and inspected by QC before any part ships.

Cleanroom Packaging Available

Parts requiring Class 8 cleanliness are packaged in sealed poly bags with desiccant and labelled with lot traceability. Sterile packaging coordination available on request.

NDA & IP Protection

All medical customers work under signed NDA. Your CAD files, design details, and device IP are never shared — secure data handling is part of our standard operating procedure.

Component Examples