Medical device components
Molded and machined components for device makers.
Molded and machined components for medical devices from JCH Design & Manufacturing. Precision tooling, molding and CNC machining to your drawing and tolerance, with verified partner-factory quality systems through vetted partner factories. For device makers diversifying out of China.
Precision molded and machined components built to your drawing, tolerance and documentation requirements — for device companies diversifying their component supply out of China. Produced at vetted partner factories with verified quality systems.
Why device makers come to us
Components you can qualify, from a supply chain you can diversify.
We make the molded and machined components that go into devices — built to your drawing and tolerance, with the first-article and documentation discipline a regulated program needs.
Tolerance you can qualify
Critical dimensions held to your drawing and proven on a measured first article per cavity or fixture, with the report you need for your records.
Verified quality systems
We work with partner factories whose quality certifications are verified and documented — and never represented as JCH’s own.
Diversify out of China
Component supply from vetted partner factories gives your device program a second source outside the China tariff and concentration risk.
Capabilities
Precision components, molded and machined.
The component-level work that feeds a device assembly — held to drawing, documented, and traceable.
Precision injection molding
Tight-tolerance molded components in engineering and medical-grade resins, tooled for repeatable dimensional control.
CNC machining
Turned and milled metal and plastic components to your drawing, with in-process and first-article measurement.
First-article & metrology
Dimensional reports against your drawing on parts from each cavity or fixture, documented for your records.
Insert & over-molding
Metal inserts and multi-material components where the device design requires them.
Inspection & documentation
In-process checks, pre-shipment inspection and the traceability documentation a regulated program needs.
Tooling & transfer
Tooling built for dimensional stability, and existing tools audited, moved and re-qualified for a second source.
Materials & construction
Specified once, then held.
Pinned down before sampling, so there is nothing to argue about once a lot is running.
- Molded materialsEngineering & medical-grade resins to your material spec
- Machined materialsStainless, aluminum, brass and engineering plastics
- ToleranceHeld to your drawing; critical dimensions called out
- First articleMeasured per cavity/fixture with a dimensional report
- DocumentationMaterial certs and traceability to your requirement
- Quality systemVerified partner-factory certifications, documented
How it works
From your files to packaged units.
- Send drawing & specThe component drawing, tolerance callouts and your documentation requirements. We sign your NDA first.
- Quote & confirm qualityWe quote the tooling or fixturing and confirm the partner factory’s verified quality system for your program.
- First-article sign-offA measured dimensional report per cavity or fixture, submitted for your approval before production.
- Produce with traceabilityProduced under QC with the material certs and traceability your records require.
- Document & shipPacked with documentation and booked to your facility.
Questions
What buyers ask first.
Do you make finished medical devices?
No — we make molded and machined components that feed your device program. Regulatory clearance of the finished device stays with you; we provide the component-level manufacturing, first-article data and documentation you need to qualify the part.
What quality certifications do you have?
The partner factories we use carry their own quality certifications, which we verify and document for your program. We never represent a partner’s ISO or other certification as JCH’s own.
Can you hold tight tolerances?
Yes — tolerance is held to your drawing, with critical dimensions called out and proven on a measured first article per cavity or fixture, documented in a dimensional report for your records.
Can you provide documentation and traceability?
Yes — material certificates, first-article dimensional reports and lot traceability to the level your program requires, agreed before production.
Why a second source for medical components?
To give your device program a qualified second source outside China’s tariff and supply-concentration risk, without moving to an unproven supply base.
Related
Diversify your component supply.
Book 15 minutes with Jack and walk through the component. He’ll tell you how to qualify a second source at vetted partner factories.
Ask for time with Jack