Representative Projects 

 

 qCPRReal-time qCPR Analysis Instrument

High throughput and high multiplex real-time PCR and capillary electrophoresis instrument capable of running up to 96 samples and reporting on up to 60 targets per sample in 2.5 hours. 
 
Assisted client in establishing documented software quality system in accordance with ANSI/AAMI/IEC 62304:2006, ISO 14971, ISO 13485, FDA Quality System Regulation 21 CFR Part 820. Worked with team to develop validation documents (requirements, design documentation, test procedures, traceability matrix.) Participated in FMEA analysis to identify possible hazards and failure as well as determine possible mitigations.

Created full automation test suite to initially test first release of application software as well as provide reliable and repeatable automated regression testing for follow up releases.

 

 BloodIntegrated Hematology System

System combines a digital morphologic analyzer, cell counter and classifier into one instrument that also makes and stains its own slides. Application counts, identifies, isolates and categorizes white blood cells, red blood cells and platelets, displaying the results within UI application allowing medical technologists to more easily focus on cells of interest.

Assisted client in establishing documented software quality system in accordance with ANSI/AAMI/IEC 62304:2006, ISO 14971, ISO 13485, FDA Quality System Regulation 21 CFR Part 820. Worked with team to develop validation documents (requirements, design documentation, test procedures, traceability matrix.) 
 
Tested application from front-end through processing to backend integration with Cerner Hospital/Laboratory Information System. Used automation, scripting and backend diagnostics tools for testing. Developed outline for COTS evaluation and documentation.
 
Assisted in the internal audit program to help ensure the compliance of the internal departments to applicable regulations.

CONTACT INFO:

Email:
info@signetmedicalsystems.com

1-978-270-5053



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