Annie Lutz

Director of Medical Device and Digital Innovation 

Annie is the team’s Director of Medical Device and Digital Innovation. With 20+ years of experience in the medical device industry, Annie provides project leadership in the quality, regulatory, technical, and logistical aspects of medical device, combination product, and SaMD validation. Annie has extensive experience interacting with the Food and Drug Administration (FDA), and guides clients through all stages of the product process – from design and development, to 510k documentation/PMA submission, to post market surveillance.