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. We began as a traditional consultancy, partnering with companies to navigate the complex landscape of global compliance.

Over time, we recognized 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, but to empower them with the tools and infrastructure to make compliance smarter, faster, and more scalable. This realization led to the creation of the LENS platform, our AI-powered RegTech SaaS solution, and our investment in secure, GPU-based hosting infrastructure.

Today, SMEDTEC is more than a consultancy, we are a hybrid ecosystem. We combine the strategic insight of our regulatory experts with the power of our intelligent platform and the security of our infrastructure. Our mission is to build the operating system for modern compliance, helping the next generation of health-tech innovators bring their products to market with confidence, clarity, and compliance built-in

Vision Statement

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.

Meet Our Founder

an image of the owner/founder of smedtec

Hello, I’m Sherif Elkhadem, the founder of 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 for SMEDTEC has always been to go beyond traditional consulting. I believe that by combining deep regulatory expertise with intelligent technology, we can create a more efficient, effective, and scalable approach to compliance. That’s why I’ve led the development of the LENS platform and our investment in technology infrastructure. My goal is to empower our clients with the tools and insights they need to succeed in a rapidly evolving industry.

At SMEDTEC, we are not just consultants; we are partners in innovation. We are committed to helping you build the future of healthcare, with compliance as a catalyst, not a barrier.