Industries
Medical & life sciences.
ISO 13485 clean-room molding and assembly for device and life-science components — documented, traceable, and built for regulated programs.
Overview
Quality that’s documented.
Regulated work demands more than a good part: documentation, traceability, and clean-room control. Our medical molding is certified to ISO 13485:2016 and built around those requirements.
We mold, assemble, mark, and package device components — so you receive finished, traceable parts ready for your process.
- ISO 13485 certified. Quality system for medical devices.
- Clean-room molding. Controlled-environment production.
- Insert molding. Rotary and shuttle insert molding.
- Validated packaging. Traceable, documented, ready to use.
Applications
Typical parts.
- Device housings & enclosures. Functional, cosmetic device parts.
- Disposables. High-volume single-use components.
- Insert-molded assemblies. Metal-to-plastic device parts.
- Marked & packaged devices. Printed, assembled, packaged.
Made in the USA. Medical molding is ISO 13485:2016 certified, with clean-room production and full traceability.
Have a project in this space?
Tell us about your part and we'll recommend the right process — and quote it fast.