Custom Medical Molding.
Clean-room molding for life-science and medical-device components — ISO 13485:2016 certified, with rotary and shuttle insert molding, sonic welding, pad printing, and validated packaging.
Clean-room precision.
Medical molding holds the precision of injection molding to a higher standard of control: clean-room production, documented process validation, and full traceability for regulated programs.
From single components to assembled, marked, and packaged devices, it's built for the requirements of the life-science and medical-device industries.
- ISO 13485 certified. Quality system for medical devices.
- Clean-room molding. Controlled production environment.
- Insert molding. Rotary and shuttle insert molding.
- Device assembly. Sonic welding, pad printing, packaging.
From print to clean-room production.
DFM & validation planning
We review the part and define the validation and documentation approach up front.
Clean-room tooling
Tooling built and qualified for clean-room production.
First articles & documentation
Inspected, documented, and traceable first articles.
Clean-room production
Controlled-environment molding to spec.
Assembly, marking & packaging
Sonic welding, pad printing, and validated packaging.
Where it fits.
- Device components. Housings, enclosures, and functional parts.
- Disposables. High-volume single-use components.
- Insert-molded assemblies. Metal-to-plastic and multi-part assemblies.
- Marked & packaged devices. Printed, assembled, ready for the field.
On the floor.
Real parts and tooling, produced through our U.S. manufacturing partner network.
Common questions.
Is your medical molding ISO 13485 certified?
Do you offer insert molding?
Can you assemble and package finished devices?
Ready to quote it?
Send your part or print for medical molding and we'll turn a quote around quickly.