<-   BioMarker Design LLC. 

IVD Industry Experience

I have over 21 years of experience in the IVD immuno and clinical diagnostic industry.  I have built assays from the ground up, optimized their processes, and transfered them into manufacturing.  I know the design control regulations very well and have submitted many assays to the FDA, cFDA, Japan, and other countries.   I am well known to many of the smaller companies who compete for buisness with some of the larger IVD companies.  I also spent several years supporting on-market products and know the weaknesses and strengths of various formats and processes and workflows.   Here is a listing of some of my skill sets: