Randy Chavez

Mr. Chavez brings 20 years of experience to the Regulatory and Quality role at Regenesis. He came aboard in 2008 with a successful track record of implementing Quality Management Systems and OUS applications for the EU, Canadian and Australian market approvals. His work at Regenesis has involved remediation and upgrade of the Quality Management System to FDA and ISO standards to bring the company forward from a specification developer to a manufacturer and release an upgraded model of the Provant Therapy System. His key Regulatory projects at Regenesis involved multiple 510(k) submissions, reclassification of the Provant from a Pre-Amendments Class III device to a Class II device, and CE Marking for expanded indications. Mr. Chavez has a B.S. in Chemical Engineering from Arizona State University (ASU) and is currently enrolled at ASU for his M.S. degree in Regulatory Science.