ABOUT ME
I'm Holly Cotter, Founder and Principal Consultant of White Lamb Consulting LLC. I bring 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 globally compliant quality management systems from scratch. I’ve supported a broad range of technologies, from active implantables and SaMD to diagnostics and respiratory systems.
Whether it's designing a multi-region regulatory strategy, creating new and evaluating existing clinical data, or building quality management systems from the ground up, I partner closely with clients to deliver compliant, forward-thinking, and business-balanced solutions.
Let’s move your medtech innovations forward—strategically, globally, and compliantly.
ORIGIN STORY
_______
White Lamb Consulting got its name in honor of my grandfather, Frank Whitelam, who was the first engineer in my family and ultimately pushed me to pursue biomedical engineering. Without him, I may not be where I am today, and for that I am forever grateful.
