EIT is ISO 13485:2015 certified and experienced with building and assembling medical electronics and devices
Capabilities:
- ISO 13485:2016
- ISO 9001:2015
- FDA Registration Experienced
- Design Support
- Quick-Turn Prototypes
- High complexity PCB and system level assembly
- Flex & Rigid Flex Assemblies
- Support for high mix and low to medium volume production
- Disaster Recovery, Scalability with (3) Domestic Manufacturing Locations
- Flying Probe, In circuit, Functional Test & Development, JTAG
- Logistics support, Kanban & Direct Order Fulfillment
- Ability to solve Component Obsolescence and Availability
- RoHS & Reach Compliance
- UL, CE, IPC-610, J-STD, Class II, III workmanship Standards
- Part Traceability
- Documentation Maintenance
Medical Device Applications Served:
- Fluid Inversion Pumps
- Lab Systems
- Imaging Systems
- Interferometers
- Blood Testing
- Cardiac Catheter
- Urinalysis
- X-Ray
- EKG