Dennis is a global leader in medical device and IVD regulatory affairs, quality, and clinical strategy. With a Ph.D. in Materials Science and Engineering and over a decade of experience spanning FDA, EU MDR/IVDR, and ISO 13485 compliance, he has successfully guided companies through complex submissions including 510(k)s, PMAs, EU MDR transitions, and COVID-19 EUAs.

Dennis has built quality systems from the ground up, led global regulatory teams, and secured market authorization across multiple device classes — from digital health and infusion pumps to implantables. At Cannulight, he ensures our products meet the highest international standards, positioning the company for successful approvals and market entry.