Heather Potter, J.D.
Heather Potter specializes in providing regulatory counsel to medical technology and pharmaceutical companies. Her practice focuses on helping clients mitigate the legal risks associated with manufacturer commercial functions and preparing regulatory opinions on various FDA topics. Heather assists clients with review of advertising, digital and social media, promotional materials, professional education, health economic and market access materials, and Sales, Marketing, Professional Education, and Reimbursement programs by applying FDA, FTC, Anti-Kickback Statute, False Claims Act, Physician Payments Sunshine Act (and related state laws), and HIPAA laws and regulations. She provides direction on how companies can lawfully interact with health care professionals and health care entities in a fashion that is compliant with the AdvaMed, PhRMA and ACCME codes.
Prior to joining Gardner Law, Heather worked in Regulatory Affairs at Medtronic. In addition, she interned at Ecolab, CryoLife, and Universal Hospital Services where her work focused on compliance, regulatory, and legal matters.
In addition to extensive experience with advertising and promotion review, Heather has trained staff on advertising and promotion requirements. She has supported manufacturers with many pre- and post- market regulatory requirements, including pre-submissions, 510(k) submissions, CE Mark renewals, 30-day notices, change control, audit (ISO 13485 and MDSAP) CAPA support, and QMS audit and remediation. She has experience drafting policies, procedures, work instructions, and agreements (including quality and regulatory agreements, among others).
In addition to practicing at Gardner Law, Heather is an Assistant Adjunct Professor at Mitchell Hamline School of Law where she teaches Drug and Device law. She has assisted in designing an undergraduate health law course offered by the school.
Heather earned her Juris Doctor (Cum Laude) from Mitchell Hamline School of Law (St. Paul, Minnesota). She attended Mitchell Hamline’s nationally ranked Health Law Institute, graduating with high honors and earning both a Health Law Certificate and a Health Care Compliance Certificate. She earned her Bachelor of Science, Corporate and Health Communication, from the University of Wisconsin-Whitewater (Whitewater, Wisconsin).
Publications: Thaddeus M. Pope & Heather M. Bughman, Legal Briefing: Coerced Treatment and Involuntary Confinement for Contagious Disease, 26 J. CLIN. ETHICS 73-83 (Spring 2015).
Office: (651) 430-7150
Mobile: (920) 723-9986