Tricia is a member of the Health Law division in the firm's Minneapolis office. She has extensive experience in the medical device industry in both regulatory compliance and regulatory affairs. She served as a consultant and technical expert on matters including new product development and testing requirements, FDA 510(k) submissions, unique device identification, changes to existing product, marketing/copy review, product labeling, complaint handling, regulatory reporting, device reprocessing and response to FDA inquiries. She also provided support and served as subject matter expert for external audits and identified high risk regulatory gaps.
Tricia's most recent experience was with the Johnson and Johnson family of companies.