Quality & Regulatory Operations

At SMEDTEC, we are deeply attuned to the unique regulatory needs of each client, particularly in the intricate and ever-evolving world of global medical device regulations. Our Quality & Regulatory Operations approach is meticulously tailored, ensuring that we address compliance requirements with unmatched precision and expertise.

We excel in supporting our clients with comprehensive regulatory solutions, including PRRC (Person Responsible for Regulatory Compliance), Quality Management System (QMS) implementation, global regulatory registrations, and Post Market Surveillance (PMS).

By leveraging our partnerships with regional experts, we offer end-to-end support across various international regulatory frameworks.

Whether it involves navigating the complexities of FDA, EMA, TGA, or other worldwide compliance challenges, our adept team is ready to guide you through every phase of the regulatory process. We craft bespoke solutions that align perfectly with your business goals, ensuring that your medical devices meet all required standards and achieve market success.

At SMEDTEC, we are committed to making your global compliance journey efficient, effective, and a resounding success.

Reach out to us to explore how our Regulatory Operations services can help you achieve regulatory excellence.

UK Responsible Person

    • Begin by filling out our comprehensive online questionnaire. You can do this by clicking the “Get Started” link now. This initial step allows us to review your medical device(s) in detail.

    • Provide information about your device(s), including type, classification, and intended use.

    • Once we receive your completed questionnaire, our team will thoroughly assess your device's specifics and regulatory requirements.

    • Based on the information provided in the questionnaire, SMEDTEC will prepare a tailored quotation.

    • Our quotation will outline the scope of services required for your device(s), along with the associated costs.

    • We ensure transparency and clarity in our pricing to provide you with the best value.

    • We will assist you in compiling and organizing the necessary technical documentation for your device(s).

    • SMEDTEC will handle the registration process of your device(s) on the MHRA Database, ensuring compliance with UK regulations.

    • Our team will keep you informed and involved at every stage of the registration process.

    • We will assist you in compiling and organizing the necessary technical documentation for your device(s).

    • SMEDTEC will handle the registration process of your device(s) on the MHRA Database, ensuring compliance with UK regulations.

    • Our team will keep you informed and involved at every stage of the registration process.

    • Once your device(s) are successfully registered, SMEDTEC continues to provide ongoing support.

    • We monitor regulatory changes and advise on maintaining compliance throughout your device's lifecycle.

    • You will have access to our expert team for any guidance or assistance needed post-registration.

Post Market Surveillance

(AI Powered)

  • Discover the Difference: Book a personalized consultation with our experts to explore your specific Post-Market Surveillance (PMS) needs. Let us understand your product line and how our AI-driven PMS process can elevate your compliance strategy.

  • We'll guide you through setting up a tailored contract and monthly subscription service that fits your business requirements.

    Our transparent process ensures you have a clear understanding of the service scope and subscription details.

    • Simplified Information Gathering: Complete a brief onboarding form to help us tailor our services to your specific needs. Just provide us with:

    • Product Type: To align our surveillance with your product’s unique regulatory landscape.

    • Brand Name: For precise tracking and monitoring in the market.

    • Manufacturer Name: To ensure full compliance and traceability.