I’ve spent the past 17+ years in medtech helping teams bring their ideas from concept to commercialization. Along the way, I’ve built and scaled quality systems, navigated FDA and international regulations, and supported launches that made a real impact for patients.
What I love most is working side-by-side with founders, executives, and growing teams to solve the challenges that come with building something new. Whether it’s:
- Setting up a right-sized QMS that won’t slow innovation
- Making sure design control, risk management, and CAPA are solid as products evolve
- Guiding teams through FDA, ISO 13485, MDSAP, or EU MDR requirements
- Supporting due diligence or investor conversations where quality and compliance questions come up
I focus on practical, actionable solutions that move the business forward.
I’ve partnered with startups and established manufacturers alike, and I understand the balancing act between compliance, innovation, and growth. My goal is always to make quality and regulatory work for the business—not against it.
If you’re building something meaningful in medtech and need someone who can jump in, simplify the complex, and help align quality with your big-picture goals, that’s where I can add value.
