Bill Kurani

Bill Kurani is an RA/QA expert with extensive experience in the area of regulatory affairs and quality assurance of in vitro, medical device. He has skills in securing global, FDA, state, and local regulatory marketing approvals with an excellent background in product design, development, verification, process validation and launch. Mr. Kurani has performed hazard and risk analysis of the product and manufacturing process helping companies deliver safe and effective products. He has lead several CAPA’s, submitted MDR, and addressed FDA 483 inspection observations & warning letters including medical device adulterated / misbranded. Mr. Kurani also lead, contributed and overseen the establishment, maintenance and performance of the several IVD and medical device company’s quality system.