Wireless Electrocardiogram System
Virtual Design Group team members lead a complete re-engineering project of the LifeSync System, the first FDA-cleared Bluetooth medical device. This included management of all aspects of the project: Planning, Analysis, Regulatory Strategy, Risk Management, Software, Electronics, Validation and Transfer to Manufacturing. Our personel led the analysis to design the project to be capable of release on a Letter to File, rather than an amended 510k, which was particularly tricky given the elements of Software, Electronics CPU (DSP replace with ARM processor) and the battery, which all required modification.
The re-engineering efforts resulted in a cost reduction of 80% on the finished unit cost, and an equal or greater amount in warranty service. After release a routine FDA audit of the project resulted in Zero Observations