Holly Cotter, RAC, RCC-MDR

Holly Cotter is Co-Founder of indieMedTech. Over the last decade, Holly has provided global regulatory, quality, and clinical expertise for medical devices, in-vitro diagnostics, and combination products. Holly has led successful strategies and submissions across diverse technologies including women’s health products, respiratory devices, cardiovascular devices, implantables, and diagnostics. Whether it’s designing a multi-region regulatory strategy, creating new or evaluating existing clinical data, or building quality management systems from the ground up, Holly partners closely with innovators to deliver compliant, forward-thinking, and business-balanced solutions. Holly co-founded indieMedTech to further her commitment to advancing medical innovation by guiding companies to market efficiently and compliantly while fostering collaboration within the MedTech community.