Bill Stoll is responsible for establishing and maintaining FDA 21 CFR Part 820 and ISO 13485:2016 Quality Systems compliance and certification at OmniSeq.
Implementing design controls via quality systems, Bill leads his team to ensure efficacious development of next level clinical tests for oncologist and pharmaceutical research. Through interaction with Regulatory agencies, he also aims to achieve market approvals for OmniSeq In-Vitro diagnostic devices worldwide.
Bill has extensive industry experience and has successfully developed more than 20 medical technologies in healthcare areas of cardiovascular, neurological and nephrological over his career. He has experience developing Clinical Trials for Regulatory product approval of medical devices and drug/device combo products with significant risk. He brings a renewed focus on Regulatory compliance and establishing relationships with regulators worldwide.