Annie Lutz
Director of Medical Device
& Digital Innovation
Ms. Lutz has 20+ years of experience working in the medical device industry coordinating and facilitating Quality, Regulatory, Technical and Logistical aspects of projects. Experiences include product development, 510K documentation, supplemental submissions to PMA, international submission documentation, post market surveillance as well as technical lead on interactions with the Food and Drug Administration. In addition, she has extensive experience in manufacturing, medical device software development, product support and product outsourcing.
Anna molded her expertise as a scientist and project leader in the professional development pipeline at Hologic, Inc. (Madison, Wisconsin) prior to joining the Innovenn team in 2013.
During her 14 years with Hologic working on in vitro diagnostics, she touched on the areas of manufacturing, quality control, process validation, product development, product support and technical support. Along the way, Anna took on leadership positions, training and coaching other scientists.
