Mona Dean

As a Vice President of Regulatory Affairs and Quality Assurance, Mona is responsible for establishing and executing regulatory and clinical strategies for digital therapeutics and maintaining the FDA and ISO 13485 compliant quality management systems.

She has over 10 years of experience in research and development, regulatory affairs, manufacturing, and quality systems in digital health, medical devices, in-vitro diagnostics, companion diagnostics, and pharmaceutical products. Her FDA regulatory experience spans the development of analytical and clinical trial protocols, Pre-Submissions, IDEs, De Novo, PMAs, and 510(k)s. She has led numerous successful product submissions in E.U., Japan, Australia, Russia, and Brazil, among other countries.