UK Market Access, Simplified and Secured
At SMEDTEC, our passion for AI-driven solutions enhances our expertise in UK Responsible Person (UK-REP) services and Post Market Surveillance (PMS) for a wide array of medical devices. We're not just navigating but redefining the landscape of medical device regulations with AI-enhanced precision, ensuring your seamless compliance and market success in the UK and EU.
Our years of experience are now augmented with AI, streamlining processes for unrivaled efficiency and insight. Our specialized UK-REP and PMS services are AI-optimized, guaranteeing not just compliance but competitive excellence for your medical devices.
We believe in a collaborative, client-focused journey. At SMEDTEC, we're your partners, empowered by AI to uniquely address the challenges of your medical devices. Our aim? To guide you to compliance and commercial triumph with AI-infused regulatory wisdom.
Join our mission as we blend AI innovation with regulatory expertise to pioneer safe, groundbreaking medical solutions in healthcare.
Our Services
-
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.
-
We offer specialized Virtual PRRC (Person Responsible for Regulatory Compliance) services specifically designed for UK's micro and small IVD manufacturers, targeting organizations with a staff headcount under 50 and a turnover or balance sheet less than €10 million. Our comprehensive service includes semi-annual audits of your Quality Management Systems and technical documentation, alongside a flexible pay-as-you-go model for post-market surveillance and vigilance activities.