EIT is ISO 13485:2015 certified at all manufacturing facilities to ensure all medical device contract manufacturing process requirements and validations are met. Medical device manufacturers choosing to work with EIT will thus find audits to be quick and easy. With all of EIT’s Electronics Manufacturing Services (EMS) facilities residing in the USA, rest assured that your intellectual property will remain protected at all times. EIT’s technological capabilities include 01005 ultra-high speed placement equipment, 3D solder paste inspection, 3D AOI and 3D X-Ray helping us produce the latest and greatest electronics systems available today for the medical device contract manufacturing industry.
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