Expertise in all things FDA
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Expertise in all things FDA
Overview
Lisa Baumhardt provides consulting to medical device, in vitro diagnostic (IVD) and combination product manufacturers. Ms. Baumhardt assists clients with a wide range of pre and postmarket regulatory topics including developing regulatory strategies, preparing regulatory submissions, drafting regulatory policies and procedures, reviewing advertising and promotional materials, and addressing enforcement matters.
In the premarket area, Ms. Baumhardt prepares 510(k)s, de novos, IDE’s and PMAs. She also prepares Pre-Submissions and Pre-Emergency Use Authorizations (EUAs) and assists clients in preparing for and representing clients at pre-submission meetings with FDA. In the postmarket area, she advises clients on design controls, risk management, complaint handling, MDRs, field actions, and QSR compliance. Ms. Baumhardt also helps clients with quality system audits and regulatory due diligence.
Prior to joining the firm, Ms. Baumhardt was the Regulatory Affairs/Quality Executive for IBM Watson Health Imaging where she was responsible for the overall strategy for quality, compliance, and regulatory. In addition, she led all healthcare authority interactions for new and novel artificial intelligence offerings. Before joining IBM, Ms. Baumhardt was the Associate Director of Regulatory Affairs for Mallinckrodt Pharmaceuticals where she was responsible for global regulatory affairs for drug-device combination products. In her 14-year career at GE Healthcare, Ms. Baumhardt held leadership roles of increasing responsibility in both Regulatory Affairs and Corporate Compliance. Ms. Baumhardt also worked at Abbott Laboratories where she was responsible for Quality and Clinical Research for a variety of in vitro diagnostic (IVD) products. In each of these roles, Ms. Baumhardt worked with cross functional development teams of all sizes in the US, Europe and Asia.