Home/Industries/Medical & Life Sciences
Industries

Medical & life sciences.

ISO 13485 clean-room molding and assembly for device and life-science components — documented, traceable, and built for regulated programs.

Made in USAISO certifiedEst. 1989
Get a QuoteExplore Capabilities
White molded plastic components moving along the production line in a clean molding cell
Clean molding cell
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.
Materials & controls

What device work demands.

Medical and life-science parts are judged on documentation as much as geometry. Programs here run under ISO 13485:2016 with clean-room molding, documented process controls, and material traceability from lot through finished part.

Resin selection is usually driven by sterilisation method, chemical exposure, and whether the part is a housing, a fluid path, or a structural component — we work through that with you before tooling is committed.

  • ISO 13485:2016. Medical-device quality system, applied to molding and assembly.
  • Clean-room molding. Controlled-environment production for device components.
  • Traceability. Material and production records suitable for regulated programs.
  • Common resins. PC, PP, PE, ABS, acetal (POM), and TPE in medical grades.
  • Insert molding. Rotary and shuttle insert molding for over-moulded components.
  • Assembly & sonic welding. Sub-assemblies joined and documented in-line.
FAQ

Common questions.

Are you certified for medical work?
Yes — our processes are certified to ISO 13485:2016 for medical-device manufacturing, alongside ISO 9001:2015 for commercial work.
Do you offer clean-room molding?
We do. Clean-room molding with documented process controls and traceability is available for device components and life-science applications.
Can you support traceability requirements?
Yes. Material and production records are maintained so regulated programs can document what ran, when, and from which lot.
What volumes suit medical molding?
Medium to high volumes suit injection tooling best. For early-stage devices or low volumes, fabrication may get you qualified parts sooner — we will tell you which fits.

Have a project in this space?

Tell us about your part and we'll recommend the right process — and quote it fast.

Get a Quote(612) 599-1939