Expert Consultancy: Strategic Guidance for Health-Tech Innovators

Our consultancy services provide you with access to fractional regulatory and quality leadership from seasoned industry experts. We go beyond tactical support to provide high-level strategic guidance that aligns with your business goals. Whether you need a fractional Head of Quality and Regulatory, support with digital transformation, or guidance on global market access, we act as an extension of your team to ensure your success.

Fractional Regulatory & Quality Leadership

Medical equipment and a computer in a bright clinic room.

Gain the benefit of senior-level expertise without the overhead of a full-time executive. We can act as your fractional Head of Quality and Regulatory, providing strategic oversight, team leadership, and representation during audits and inspections. This model is ideal for organizations that need high-level guidance but are not yet ready for a full-time hire.

Learn more
Black and white portrait of a man wearing glasses and a suit in an office setting.

UK-RP & EU-AR Services

    • 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.

Get Started
Futuristic digital display with data charts and patterns

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.

Get Started