Bill Kurani

SVP Regulatory Affairs, Clinical Affairs, and Quality Assurance at Antrix

Speaker

Mr. Bill Kurani – MSRA (SDSU), MSEE (LSU), BC (Stanford) has extensive experience in the area of regulatory affairs and quality assurance of medical device including regulatory clearances from FDA, EU as well as other global regulatory bodies. Mr. Kurani has helped several medical device companies implement successful QMS based on ISO 13485, FDA, MDSAP, and IVDR, including product design, validation and manufacturing process programs. He has done hazard and risk analysis on many aspects of the medical device design and manufacturing process. Mr. Kurani has setup successful post market surveillance and vigilance systems adhering to FDA, EU IVDR, and ROW regulations in several companies. Mr. Kurani currently actively involved in development and commercialization of Next Generation Sequencing Genomics product.