J. Lawrence Stevens, RAC

J. Lawrence Stevens, RAC is an FDA regulatory compliance expert specializing in the regulation of medical devices. With extensive experience in FDA field positions and industry roles, he brings a comprehensive understanding of regulatory frameworks and quality systems to his litigation work. His work centers on investigating FDA compliance issues, assessing regulatory submissions, and evaluating whether quality systems meet international standards.

Mr. Stevens has been retained in numerous expert witness and consulting engagements across the United States, involving medical device regulation and compliance cases. His Bachelor of Arts in Biological Sciences, along with his Certified in Regulatory Affairs (RAC) certification, reinforce his ability to deliver objective, defensible analyses. He is regularly engaged by both plaintiff and defense counsel to provide clear, independent determinations of regulatory compliance in disputes involving FDA medical device regulations.