This is now our largest and fastest growing industry segment. We have focused on specimen collection devices, vital signs monitor housings, labware, research tools, stents and surgical devices to name a few.
We primarily focus on Class I devices and Class II components but welcome a conversation regardless of device class.
Capabilities
- ISO 13485
- ISO Class 7 Clean Room
- FDA Registered Facility & compliant with 21 CFR Part 820
- New product development support and DFM
- Ready for market packaging
- Over molding
- Ultra sonic welding, pad printing, laser etching, inserting, and hot stamping
- In mold sensors to aid in validation and production process control
- IQ/OQ/PQ validation of manufacturing processes
- Commercial sterilization support
- Stock USV VI – ISO 10993-1 materials for volume purchasing
- Small part production is a speciality to 0.5 grams in size
- Mold flow analysis
