Holly Cotter, RAC, RCC-MDR

SENIOR REGULATORY CONSULTANT

Holly Cotter is a seasoned regulatory, quality, and clinical leader with a decade of hands-on experience supporting global medical device, IVD, and combination product development. As Founder and Principal Consultant of White Lamb Consulting and Co-Founder of indieMedTech, Holly specializes in navigating complex regulatory, clinical, and quality landscapes across the U.S., EU, UK, Canada, and additional international markets.

Her background spans early-stage startups to Fortune 500 MedTech organizations, where she has led successful regulatory submissions—including FDA 510(k), IDEs, Health Canada approvals, and EU MDR/IVDR technical documentation—designed and executed clinical strategies, and built globally compliant quality management systems from the ground up. She has supported a broad range of technologies such as active implantables, women’s health products, respiratory devices, cardiovascular systems, diagnostics, and software as a medical device.

Holly partners closely with innovators to deliver compliant, forward-thinking, and business-balanced solutions—whether developing multi-region regulatory strategies, generating or assessing clinical evidence, or architecting quality systems that scale. Her approach blends technical rigor with practical execution, ensuring companies advance efficiently toward clinical, regulatory, and commercial milestones.

As Co-Founder of indieMedTech, Holly furthers her commitment to strengthening the MedTech ecosystem by cultivating collaboration among independent professionals, building partnerships that elevate industry expertise, and creating resources that help MedTech professionals support innovation of impactful health technologies. For Holly, this work is about empowering the professional community that drives healthcare innovation.

For more information, please see her LinkedIn Profile.