Capabilities

1) 2000 square foot office and laboratory

2) Strong network of distributors, manufacturers representatives, and contract manufacturers

3) Solid understanding of BLDC, motors and motor controllers

4) Design Review / Code Review Services

5) Use of Smart batteries – including Li-ion Fuel Gauging, SMBus Comm, Chargers/Conditioners

6) User Needs and Requirements Generation – DIR, SRS, DR, Traceability Matrices

7) Risk Management per ISO 14971:2012 – Hazard Analysis, FMEA, Risk Management Plan, Risk Matrix

8) Verification and Validation testing and reporting

9) 25+ years of medical device design, development, roll-out

10) 15+ years on predicate VAD and TAH systems

11) Systems Engineering and Integration

12) Analog and Digital Electronic circuit design including modeling,
simulations, pcb layout, etc.

13) Firmware and software design to IEC 62304 standard

14) Algorithm Development for physiologic control

15) Useability to IEC 62366 standard

16) Assembly services, prototype builds, etc.

17) Mechanical 2D and 3D Modeling – Enclosures, packaging, panels, complex mechanical and electro-mechanical assemblies, etc.  with simulations and dynamic analysis.

18) Miniaturization, packaging, SPC reduction

19) Reliability Prediction Analysis

20) Design for EMC Compliance / EMC Compliance Testing (using 3rd party lab)

21) Design for Electrical Safety / Electrical Safety Testing (internal + using 3rd party lab)

22) Design for Environmental Compliance / Environmental Testing (using 3rd party lab)

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