Alberto Gutierrez, PhD is a Partner with NDA Partners and has worked with the company as an Expert Consultant since 2017. He is an expert in preclinical and clinical testing of in vitro diagnostic devices and radiological imaging devices, premarket notifications of devices, applications for approval, and post-marketing surveillance and compliance. Dr. Gutierrez oversaw the Personalized Medicine Staff at the FDA and developed and managed the policies surrounding companion diagnostic devices. Dr. Gutierrez was also a member of the Center for Devices and Radiological Health committee that oversaw policies on Digital Health.