Lisa Baumhardt

Lisa Baumhardt, Senior Director of Regulatory Affairs at CovarsaDx, provides regulatory consulting services to medical device and in vitro diagnostic (IVD) manufacturers. She advises clients on a broad range of premarket and post market regulatory matters, including regulatory strategy, FDA submissions, advertising and promotional materials, enforcement matters, quality systems, and regulatory compliance.

In the premarket area, Lisa prepares 510(k)s, De Novo requests, Emergency Use Authorizations (EUAs), Humanitarian Device Exemptions (HDEs), and Premarket Approval Applications (PMAs). She also prepares pre-submissions and assists clients in preparing for and participating in meetings with the FDA. On post market matters, she advises clients on compliance with the Quality Management System Regulation (QMSR), including Medical Device Reporting (MDR), Reports of Corrections and Removals, and recalls. She also assists clients with quality system audits and regulatory due diligence.

Before joining CovarsaDx, Lisa was a Principal Medical Device Regulatory Expert at Hyman, Phelps & McNamara, P.C. Previously, she served as Regulatory Affairs/Quality Executive for IBM Watson Health Imaging, where she led the overall quality, compliance, and regulatory strategy and managed healthcare authority interactions for new and novel artificial intelligence offerings. Lisa also served as Associate Director of Regulatory Affairs at Mallinckrodt Pharmaceuticals, where she was responsible for global regulatory affairs for drug-device combination products. During her 14-year career at GE Healthcare, she held leadership positions of increasing responsibility in Regulatory Affairs and Corporate Compliance. Earlier in her career, she worked at Abbott Laboratories, where she was responsible for Quality and Clinical Research for a variety of IVD products.

Throughout her career, Lisa has partnered with cross-functional product development teams of varying sizes across the United States, Europe, and Asia, bringing extensive experience in regulatory strategy, quality systems, compliance, and the development and commercialization of innovative medical technologies.

Lisa holds a Bachelor of Science in Medical Technology from Marquette University, a Master of Science in Healthcare Technology Management from the Medical College of Wisconsin/Marquette University and a Master of Jurisprudence with a concentration in Health Law from Loyola University Chicago School of Law.  She holds her Regulatory Affairs Certification (RAC) from RAPS and has been honored as Fellow (FRAPS) exemplifying integrity, service, and commitment to the global regulatory community.