Electrical & Mechanical Design Engineering Services and Medical Device Manufacturing Capabilities

Our 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 Compliant

Product Manufacturing Expertise in the Following Disciplines:

• Electrical – low power through high power analog design, wireless design, low noise design, embedded digital design
• Mechanical – fluidics, kinematics, mechanism design, CFD thermal and stress analysis, robotics, injection molded part design, sheet metal and casting design
• Software – real time embedded system design, coding, DSP, signal analysis
• Verification and 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

Integrated Transitional Manufacturing through Sustaining Manufacturing

Lean Flow Manufacturing

• Combination of Lean Flow techniques, CPI and 5S
• Product Assembly & Testing
• Documentation Control

Materials Management

• Product Forecasting
• Distribution Service
• Service and Repair

Medical Device Manufacturing Products

ENEPIG Printed Circuit Boards

High Density Interconnection Microvia

Contact HEI today for the best in Medical Device Manufacturing Electrical & Mechanical Design Engineering Services.