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Medical device design and manufacturing is an expert capability of leading EMS provider, HEI, Inc. HEI’s medical device contract manufacturing expertise includes a variety of diagnostic, analytical and life science technologies, including Class III medical devices, higher-level assemblies and box builds, printed circuit board design and assembly services.
HEI will help you plot a course through the complex regulatory environments for medical devices, both domestic and international. HEI’s electrical and mechanical engineering services facility is FDA-registered, ISO 13485:2008 Certified - FDA QSR Class I, II and III - UL IEC 60601-1-4 & ISO 14971 and Quality System Regulation (QSR) compliant.
HEI’s Medical Device Manufacturing expertise includes the following disciplines:
Electrical – low power through high power analog design, wireless design, low noise design, embedded digital design and RF biotelemetry from kHz to GHz.
Mechanical – fluidics, kinematics, mechanism design, CFD thermal and stress analysis, robotics, injection molded part design, sheet metal and casting design
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Software – real time embedded system design, coding, DSP, signal analysis
Verification / Validation - Session Based Testing, requirements tracing and testing, regression testing
Optical – imaging and low signal fluorescence microscopy, lasers and con-focal imaging systems
Iterative/Phase Gate Design and Development Controls
Lean Flow Manufacturing
- Lean Flow techniques, CPI and 5S
- Medical Device Assembly & Testing
- Documentation Control
Materials Management
- Product Forecasting
- Distribution Service
- Calibration, Re-Certification, and Repair
Examples of HEI Medical Device Capabilities and Expertise include:
Diagnostic Instruments
- DNA-based Microbiology System
- DNA Test System (Optical Platform)
- Electrochemical DNA analysis system
- Hematology Analyzer
- Hematocrit/Hemoglobin Analyzer
- Blood Coagulation Testing
- Antibody Screening System & Cardiac Test System
- Slide Stainer System & Immunoassay System
- Point of Care Analyzer
- Glucose Meter
- Magnetic Particle Suspension/Re-suspension
- Electrophoresis System
- Low Cost Optical Test Station
- High volume immunoassay system
Therapeutic Instruments
- Defibrillator & Restinosis Treatment
- Current Control (Aneurysm Treatment)
- Transcutaneous Electronic Nerve Stimulator (TENS)
- Transdermal Drug Delivery Unit
- Sleep Therapy Unit & Pulse Oximetry
- Uterine Bleeding Treatment
- IV/Drug Compounder & IV Infusion Pump
- Insulin Infusion System
Medical Device Manufacturing Products
Medical Device Manufacturing Capabilities
ENEPIG Printed Circuit Boards
High Density Interconnection Microvia
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