MD Sur Consulting
Regulatory consulting for medical devices, cosmetics, and biocides
In the dynamic field of pharmaceutical consulting, our team of experts stands out for its creativity and excellence.
We focus on providing you with effective regulatory solutions, delivering specialised and tailored advice.
We support you so that you can market in Spain and the European Union with confidence: licences, registrations, technical documentation, UDI, and post-market surveillance.
Welcome to Medical Devices Sur Consulting, your strategic partner in regulatory consulting
At MD Sur Consulting, we help companies that manufacture, import, assemble, distribute or export products to comply with regulations and reach the market without obstacles.
We work agilely, with a practical approach, and provide support before, during and after placing products on the market.
Why choose us?
At Medical Devices Sur Consulting, we offer you a professional and tailored service based on your business model, and we swiftly manage the processing of every step.
Our team will support you throughout the entire process: from licences and registrations to post-market activities, ensuring full regulatory compliance.
We work in alignment with the regulatory frameworks applicable to medical devices and in vitro diagnostics (MDR / IVDR), as well as national requirements, to ensure robust and defensible market access.
We offer a multilingual service: Spanish, English, French and Korean, so you can import your products from anywhere in the world.
Regulatory advice and end-to-end management
From regulatory advice to end-to-end management of procedures, we take care of the entire process required to place your products on the market.
We specialise in registration and obtaining certifications, such as CE marking for medical devices, as well as managing licences and responsible declarations for cosmetics.
Our approach is based on experience, efficiency, and continuous updates on current regulations.
We work with you to overcome regulatory barriers, minimising risks and maximising your products' potential for success.
Comprehensive consulting for medical devices and pharmacy
At Medical Devices Sur Consulting, our speciality is providing comprehensive consulting in the pharmaceutical sector and in medical devices. Our experts provide support with obtaining licences, tailored market strategies, and regulatory requirements.
We are committed to guiding our clients through every step of the process, ensuring their products meet the most stringent criteria and reach the market efficiently. With a personalised approach, we strive to maximise the potential of their innovations in the challenging world of medical devices and pharmaceuticals.
We excel in tailored pharmaceutical consulting
We stand out for providing regulatory, innovative and tactical solutions for the pharmaceutical and cosmetics sectors. With a deep understanding of local and European regulations, we are experts in facilitating CE marking for medical devices, ensuring they meet the highest safety and quality standards.
We tailor our solutions to each client's specific needs, offering close, personalised support at every stage of the regulatory process. From registration to obtaining certifications and licences, we handle everything, allowing our clients to focus on their business with the certainty that they are in professional hands.
Specialisation in the pharmaceutical and cosmetics sectors
We are experts in specific regulations for medical devices and cosmetics, with in-depth knowledge of local and European requirements.
Comprehensive and strategic support
We provide full technical support across all phases of the product, from the initial idea to placing it on the market, with expert advice.
Proven experience and a practical approach
We have extensive experience working with companies in the sector, applying realistic solutions tailored to each project.