Adrienne R. Lenz

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.