Quality & Regulatory Compliance Made Easy for Start-ups

At SMEDTEC, we specialize in providing global regulatory services to help startups bring their medical devices to market efficiently and affordably. With over a decade of experience, we understand the unique challenges startups face and tailor our solutions to fit your needs, ensuring seamless compliance without compromising your budget.

We develop regulatory strategies, implement Quality Management Systems (QMS), conduct clinical evaluations, and manage Post-Market Surveillance (PMS). Our expertise spans all classes of medical devices, including emerging technologies in Digital Health and AI.

As a team that embraces innovation, we believe in the words of Charles Darwin: “It is not the strongest of the species that survives, nor the most intelligent, but the one most adaptable to change.” At SMEDTEC, we adopt the latest tools (yes, including a lot of AI) to make regulatory compliance smarter, faster, and more accessible—so you can focus on building groundbreaking medical technologies.

Startups are at the heart of what we do. Combining precision, collaboration, and a deep commitment to your success, we streamline the path from concept to commercialisation.

Adapt, thrive, and grow. Let us guide you through compliance with confidence and clarity.

Contact us today to learn how we can support your journey.

Our Services

  • SMEDTEC's Quality & Regulatory Operations services provide end-to-end support to ensure your medical devices meet global regulatory standards. From building regulatory teams and implementing QMS to managing UK-REP, PMS, and compliance with international requirements, we help you navigate the complex regulatory landscape efficiently. Our services ensure your device is not just compliant but positioned for success in the global market

  • SMEDTEC provides ongoing post-market surveillance services, ensuring that medical devices continue to meet safety and efficacy standards after they have entered the market.

  • SMEDTEC offers expert advice on regulatory strategy. We can support with registrations and applications in all of the major regions including the USA, EU, UK and Australia. We can support with 510k’s or ARTG entry applications. Whatever you need we will find a solution for you!

  • SMEDTEC acts as a UKRP for non-UK medical device manufacturers, managing all aspects of compliance with UK regulations. This includes device registration, maintenance of technical documentation, and liaison with the MHRA (Medicines and Healthcare products Regulatory Agency).

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