Lisa M. Baumhardt Senior Medical Device Regulation Expert 202-737-4589

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.

Education & Admissions

Education

M.J., Health Law, Loyola University Chicago, 2013
M.S., Healthcare Technology Management, Medical College of Wisconsin / Marquette University, 2008
B.S., Medical Technology, Marquette University, 1987

Admissions

RAC-US, Regulatory Affairs Professional Society
FRAPS (Fellow in Regulatory Affairs), Regulatory Affairs Professional Society

Experience

  • Prepares and reviews product submissions, including, 510(k)s, de novos, PMAs, IDEs, Pre-Submissions, and Pre-EUAs.
  • Assists clients in responding to FDA deficiency letters and requests for additional information
  • Evaluates and develops regulatory and marketing strategies.
  • Assists with determining regulatory requirements for product modifications, including design, supplier, and manufacturing changes.
  • Advises on design control, testing and risk management.
  • Advises on MDRs, complaint handling, recalls, corrections, and removals.
  • Advises on enforcement actions, including, 483s and warning letters.
  • Prepares regulatory procedures (e.g., design control, complaint handling, UDI, MDR).
  • Reviews promotional material and labeling.
  • Performs regulatory due diligence for mergers and acquisitions.
  • Assists companies with Quality System Regulation (QSR) matters.

Honors & Awards

IBM: Women of Watson Health Award, 2020

IBM: Critical to Success Award, 2019

GE Healthcare: Healthcare Hero Award, 2009, 2008, 2007

GE Healthcare: Management Award, 2007, 2006, 2005, 2004

Speaking Engagements

  • RAPS Regulatory Convergence: Software as a Medical Device – Has AI Learned too Much?, September 15, 2020
  • FDA Public Workshop on The Evolving Role of AI in Radiological Imaging: Artificial Intelligence in Breast Cancer Screening Program: Clinical, Technical, and Regulatory Considerations, February 25, 2020
  • RAPS Regulatory Convergence: Regulatory Case Studies in Artificial Intelligence, October 4, 2018
  • RAPS Wisconsin Chapter: 510(k) Basics and Beyond, March 13, 2018
  • Loyola University Chicago: Off Label Prescribing and the Practice of Medicine, May 13, 2013
  • Marquette University, Guest Lecturer: Global Regulatory Affairs and Standards, 2009-2010
Education

M.J., Health Law, Loyola University Chicago, 2013
M.S., Healthcare Technology Management, Medical College of Wisconsin / Marquette University, 2008
B.S., Medical Technology, Marquette University, 1987

Admissions

RAC-US, Regulatory Affairs Professional Society
FRAPS (Fellow in Regulatory Affairs), Regulatory Affairs Professional Society

Practice Areas
Industries
FDA Regulatory Categories