Capabilities

1) 4000 square foot office and laboratory space 2 miles from NYC metro hospitals, universities, contract manufacturers, airports, etc.

2) Clinical support to NY/NJ metro hospitals

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

4) Solid understanding of BLDC, Stepper, DC, AC motors and motor controls

5) Design Review / Code Review Services

6) Design of Smart batteries including NiMH, LiIon, NiCd. – including Fuel Gauging, SMBus Comm, Chargers/Conditioners

7) Requirements Generation – DIR, SRS, DR, Traceability Matrices

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

9) Real-time data monitoring via global network – a scalable network that’s already deployed and running for >4 years

10) Verification and Validation testing and reporting

11) 25+ years of medical device design, development, roll-out

12) 15+ years on predicate VAD and TAH systems

13) Systems Engineering

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

15) Firmware and software design to IEC 62304 standard

16) Algorithm Development including numerous algorithms for physiologic control,
ventricular suction detection, blood flow estimation, filters, threshold
detectors, etc. using Time Domain, Frequency Domain, and Phasor Domain methods

17) Useability to IEC 62366 standard

18) Assembly services, prototype builds, etc.

19) Mechanical 2D and 3D Modeling – Enclosures, packaging, panels, complex mechanical assemblies, etc.

20) Miniaturization, packaging, SPC reduction

21) Reliability Prediction Analysis

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

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

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

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