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

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