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Medical Device Design and Medical Device Manufacturing

 

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

Medical Device Manufacturing

 

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


HEI designs, manufactures and tests advanced electronic components for the medical device industry, military and aerospace, and broadband telecommunications markets.

Contact HEI today for the best in Medical Device Design and Medical Device Manufacturing capability.

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