Adrienne R. Lenz Senior Medical Device Regulation Expert 202-737-4292

Overview

Adrienne Lenz provides consulting to medical device and combination product manufacturers. Ms. Lenz assists clients with a wide range of pre and postmarket regulatory topics including developing regulatory strategy, preparing regulatory submissions, drafting regulatory policies and procedures, reviewing advertising and promotional materials, and addressing enforcement matters.

In the premarket area, Ms. Lenz prepares IDEs, 510(k)s, de novos, and PMAs. She also prepares pre-submissions, and assists clients in preparing for and represents clients at pre-submission meetings with FDA. In the postmarket area, she advises clients on design controls, risk management, MDRs, field actions, and QSR compliance. Ms. Lenz also helps clients with quality system audits and regulatory due diligence.

Prior to joining the firm in 2017, Ms. Lenz worked as an independent regulatory consultant and consultant with Emergo.  She has also held positions in regulatory affairs, quality assurance, and test engineering at GE Healthcare and Smiths Medical.  In these roles, Ms. Lenz conducted a range of regulatory, quality, and engineering functions working with medical device companies and development teams of all sizes in the US, Europe and Asia.

Education & Admissions

Education

M.S., Physiology, Medical College of Wisconsin
B.S., Biomedical Engineering, Milwaukee School of Engineering

Admissions

RAC-US
Regulatory Affairs Professional Society

Experience

  • Prepares and reviews product submissions, including, 510(k)s, IDEs, and Pre-Submissions.
  • 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 and complaint handling, recalls, corrections, and removals.
  • Advises on enforcement actions, including, 483s and warning letters.
  • Prepares regulatory procedures (e.g., design control, risk management).
  • Reviews promotional material and labeling.
  • Performs regulatory due diligence for mergers and acquisitions.
  •  Assists companies with Quality System Regulation (QSR) matters.
Education

M.S., Physiology, Medical College of Wisconsin
B.S., Biomedical Engineering, Milwaukee School of Engineering

Admissions

RAC-US
Regulatory Affairs Professional Society