Katie Reneson is a Regulatory Specialist and Consultant for Ken Block Consulting. Katie utilizes her eight years of industry experience to solve complex regulatory compliance problems and assist clients in receiving marketing clearance for their devices. Areas of expertise include device validation, software validation, process validation, 510(k) applications, European Medical Device Regulation, and In Vitro Diagnostic Regulation. Due to the increased regulatory demands of the new Medical Device Regulation and ISO 13485:2016 Ken Block Consulting has recently opened an office in Europe.
Company:Ken Block Consulting