Where Start-ups Thrive: Smarter Regulatory Solutions
At SMEDTEC, we specialize in Regulatory Operations, Quality Management Systems (QMS), and Post Market Surveillance (PMS)—key pillars of medical device compliance in the UK, EU, and global markets. We’re passionate about supporting startups and emerging companies, providing affordable, tailored regulatory solutions to help you achieve seamless market entry and long-term success.
Regulatory compliance can be complex, but we make it approachable. Whether you’re looking for hands-on support with UK Responsible Person (UK-REP) services, proactive PMS, or building and streamlining your regulatory processes, SMEDTEC operates as an extension of your team. We don’t believe in off-the-shelf solutions—every medical device is unique, and so is our approach. We partner with startups to develop strategies that fit your product, your business, and your growth ambitions.
We bring deep expertise in navigating the UK’s regulatory framework, the EU’s MDR/IVDR requirements, and broader global markets. Our solutions include:
Comprehensive UK-REP Representation and global registration services
Post Market Surveillance (PMS) for safety and performance monitoring
QMS Implementation for ISO 13485 and market readiness
Tailored Regulatory Consultancy designed specifically for startups
At SMEDTEC, we combine precision, innovation, and collaboration to deliver regulatory excellence. Think of us not just as consultants but as partners in your journey. We thrive on working with startups—those pushing boundaries, innovating medical technologies, and transforming healthcare.
“In a world where you must adapt or be left behind, we embrace the tools, the innovation, and yes, the AI, to make your regulatory journey smarter, faster, and smoother.”
Together, let’s shape the future of medical devices. With SMEDTEC by your side, you can confidently bring safe, effective, and ground breaking healthcare solutions to homes and hospitals worldwide.
Meet Our Founder
Hello, I’m Sherif Elkhadem, the founder and driving force behind SMEDTEC. With over a decade of experience in the medical device and biopharmaceutical industries, I’ve worked across global regulatory registrations, Post Market Surveillance (PMS), and even large-scale projects, including for the UK Government. My journey has taken me from the hands-on development of diagnostic assays and quality control to mastering ISO standards and FDA regulations.
But here’s what really excites me: helping startups navigate the regulatory maze and turn their groundbreaking ideas into market-ready medical devices. I know firsthand that the regulatory world can feel daunting—especially for emerging companies—but with the right support, it doesn’t have to be.
At SMEDTEC, we’ve taken a modern approach to compliance. Yes, we embrace AI (because “if you don’t adapt, you get left behind”), but it’s about more than just technology. We combine human insight with cutting-edge tools to deliver smarter, faster, and more affordable solutions for startups like yours. AI minimizes errors, maximizes productivity, and lets us focus on what matters most: helping you bring safe, innovative medical technologies to life.
What truly sets SMEDTEC apart is our belief in building genuine partnerships. Startups are at the heart of what we do, and we’re here to walk alongside you—every step of the way. Whether you need help with global regulatory strategies, QMS implementation, or Post Market Surveillance, think of us as your dedicated partners in success.
Let’s simplify compliance and unlock your growth together. Join us on this exciting journey, where expertise meets innovation, and where your medical device isn’t just compliant—it leads the way.