Product Overview
We mould medical device housings and fluidic components under ISO 13485:2016, so the process controls, the documentation and the change management follow a medical quality system rather than a general engineering one.
Medical parts are usually small, often thin-walled, and almost always appearance-critical, so the mould has to be built for the surface as much as for the dimension. We specify the cavity steel for the finish you need and vent the tool so thin sections fill without burning.
Quality system
- ISO 13485:2016 alongside ISO 9001:2015 and IATF 16949:2016
- Lot traceability from resin batch to finished part
- Change control on any tool or material modification
- Clean handling and packing to the agreed standard
Typical parts
- Device housings, enclosures and covers
- Fluidic components, luer fittings and valve bodies
- Syringe and dispenser components
- Surgical instrument handles and overmoulded grips
Material is selected to your drawing. The grades listed are the ones we run most often for this type of part; we confirm the choice at DFM rather than assuming it.