The eSensor® 4800 is the first generation in-vitro DNA diagnostics instrument produced by Osmetech Molecular Diagnostics.  I personally wrote all of the initial instrument control software, including the graphical front end (as System Integration).  As an employee, I managed the contractors responsible for the embedded circuitry and firmware, and who supported the mechanical design.  My team wrote and executed the manufacturing and repair procedures.  I was responsible for the hardware and software validation, the instrument and software sections of the FDA 510(k) submission and defended the complete  design and validation before ISO and FDA auditors.