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