Denver, Colorado
A 56,000 sq.ft. (2,500 sq.m.) facility featuring a state-of-the-art clean room (ISO 7) and equipped for high-volume manufacturing of microfluidic devices and critical components essential to the in vitro diagnostics (IVD) market.
Component Capabilities
- Off-the-Shelf standard reagent filled blisters, custom fill solutions
- Custom reagent blister dDesigns, custom fill solutions
- Disposable cartridge sub-assemblies, custom component designs
- Full disposable cartridge design, prototype, test, qualification, verification, validation, design transfer
- Product design test data generation supporting FDA 510(k) submission package
Manufacturing Process Capabilities
- Laser welding
- Laser cutting
- Ultrasonic welding
- Heat staking
- Heat sealing
- Precision liquid dispense
- Liquid fill and seal
- Liquid fill and seal in controlled atmosphere
- Liquid fill and seal under vacuum
- Custom liquid handling
- Reagent blister fabrication, fill, seal
- Automated vision system inspection
- Automated Mass inspection
- Functional test inspection
- Custom test fixture inspection
Services
- R&D prototyping services
- Manufacturing services
- Start-up to high volume contract manufacturing
- Design for manufacturability
- Manufacturing process development
- Quality inspection process development
- Mature design revision for cost reduction
- High volume manufacturing automation design, fabrication, installation, qualification, operation
Contact
15030 Compark Blvd
Suite 110
Parker CO 80134
USA
+1-303-762-1693
Certifications
- Product design test data generation supporting FDA 510(k) submission package
- ISO 13485
