I’m Holly Cotter,  principal consultant of White Lamb Consulting LLC and Co-Founder of indieMedTech. I bring over a decade of hands-on experience in global medical device, IVD, and combination product development—with a specialty in navigating complex regulatory, quality, and clinical landscapes across the U.S., EU, UK, Canada, and other global markets.

My background spans early-stage startups to Fortune 500 medtech leaders, where I’ve led regulatory submissions (FDA 510(k), IDEs, Health Canada, EU MDR/IVDR), developed and implemented clinical strategies, and built or remediated quality systems to align with international standards. I’ve supported a broad range of technologies, from active implantables and SaMD to diagnostics and respiratory systems.

Whether it’s designing a first-in-human clinical study, leading a technical file remediation, or building post-market surveillance systems from the ground up, I partner closely with clients to deliver practical, compliant, and forward-thinking solutions.

Let’s move your innovations forward—strategically, globally, and compliantly.