Isabella Schmitt

With a diverse background spanning regulatory affairs, clinical trial design and management, product management, and quality assurance, Isabella has a unique blend of expertise to drive success for any medtech program. She has guided regulatory, quality, and clinical initiatives for over 100 successful regulatory filings and FDA interactions. She has also authored articles for multiple publications, participated in numerous podcasts, and engaged in speaking opportunities covering regulatory affairs submissions and interactions for medical devices and AI/ML in healthcare. As a member of the AAMI/ISO Standards working group, she also helped to establish Application Of ISO 14971 To Machine Learning In Artificial Intelligence. She has a RAC Certification, Master’s in Business Administration, and a Bachelor’s of Science in Chemistry and has won awards for success in business, including the Stevie’s Business Award as well as Houston Business Journal’s Award for Women to Watch, and Cardiovascular Business 40 under 40.