Regulatory Operations for Hassle-Free Market Entry

At SMEDTEC, our expertise in Regulatory Operations encompasses the global process of ensuring that medical devices are compliant with regulatory requirements before they are used and marketed. Regulatory Operations at SMEDTEC includes building teams for Quality Management System (QMS) implementation, managing regulatory obligations, and providing specialized services such as UK Responsible Person (UK-REP) and Post Market Surveillance (PMS) for medical devices.

With years of hands-on regulatory experience, we streamline processes to ensure efficiency and compliance.

Additionally, Our specialised UK-REP and PMS services are tailored to meet regulatory requirements while also fostering strategic growth and competitive excellence for your medical devices.

We believe in a collaborative, client-focused approach. At SMEDTEC, we're your dedicated partners in Regulatory Operations, uniquely addressing the challenges of your medical devices and helping you build the necessary infrastructure for success. Whether you need UK-REP services, PMS, or support with QMS and regulatory team-building, we are here to guide you towards compliance and commercial success.

Join us as we combine regulatory expertise with innovative solutions to pioneer safe, groundbreaking medical technologies.

Our Services

  • SMEDTEC's 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 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).

  • 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, compliance, and quality management system (QMS) implementation, helping clients to achieve and maintain market approval for their medical devices.

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