Building the Operating System for Modern Compliance
SMEDTEC was founded on a simple principle: to provide expert regulatory and quality guidance to medical device and IVD innovators.
SMEDTEC began as a traditional consultancy, partnering with companies to navigate the complex landscape of global compliance — EU MDR, IVDR, FDA, MHRA, and beyond. We embedded ourselves in our clients' teams, acting as fractional RA and QA leadership for companies that needed expertise without the overhead of a full in-house function.
Over time, we recognised that the future of regulatory affairs lies at the intersection of human expertise and intelligent technology. We saw an opportunity not just to guide our clients through compliance, but to give them the tools to own it — leading to the creation of SMEDTEC OS, our AI-powered regulatory operations platform.
Today, SMEDTEC is more than a consultancy. We are a hybrid ecosystem — combining the strategic insight of our regulatory experts with the power of our intelligent platform. Our mission: build the operating system for modern compliance, and help the next generation of health-tech innovators bring their products to market with confidence, clarity, and compliance built in.
SMEDTEC is building more than a consultancy — it's building the operating system for modern compliance. By combining people, process, and platforms, we help the next generation of health-tech innovators bring products to market with confidence, clarity, and compliance built in.
Founder & CEO · SMEDTEC
With over a decade of experience in the medical device and biopharmaceutical industries, I've seen firsthand the challenges that innovators face in bringing their products to market. I founded SMEDTEC to bridge the gap between regulation and innovation.
My vision has always been to go beyond traditional consulting — to combine deep regulatory expertise with intelligent technology and create a more efficient, scalable approach to compliance. That's what led to SMEDTEC OS, and what drives everything we build.
At SMEDTEC, we're not just consultants. We're partners in innovation, committed to making compliance a catalyst — not a barrier.
