We prepare all the technical documentation your product needs to obtain CE marking

Consultoria producto sanitario Equipo Episkey

At EpisKey Medical Consulting we work with a team of specialists with extensive experience in medical devices consultancy, and willing to collaborate. We carry out projects that deal with obtaining the distribution licence for medical devices, applying for the CE marking required for a medical device to be marketed in the European Union or training our clients to act as Technical Responsible for their product.

We know exactly how to classify your medical devices according to the new regulations and we are used to working in a changing and technological environment. We offer solutions to the medical devices industry adapted to your situation: permits, authorisations, regulations, certifications, etc.


We help medical device manufacturers comply with health regulations applicable to their products

Our team


Regulatory Strategy

Use of health software

Clinical evaluation and performance

Technical documentation


  • En EpisKey somos muy conscientes de la importancia de llevar a cabo investigaciones clínicas en aquellos productos sanitarios que así lo requieren. Además sabemos que es vital llevar a cabo el proceso de autorización por parte de las autoridades competentes del país donde se ejecutarán......

  • Our Universo Regulación is back, the podcast that talks about medical devices and how they are regulated. In this programme, Isabel talks about the importance of being clear about what the acronyms of international standards stand for. We explain why complying with an ISO standard......

  • ¡New programme of Universo regulación! We talked to Isabel about what an in vitro diagnostic medical device is and how these special products are regulated. He tells us that these are products that do not come into contact with the patient himself, but with a......

  • Restrictions adopted due to the coronavirus pandemic are gradually being relaxed. The options to participate in face-to-face meetings are increasing. Through Ticbiomed, we are informed of the call for the Forum on Innovation and Digital Transformation in Health for March 16 in Murcia. At Episkey......

EpisKey Tips

Our clients

Episkey Medical Consulting SL in the framework of the ICEX Next Program, has been supported by ICEX and co-financed by the European ERDF fund. The purpose of this support is to contribute to the international development of the company and its environment.

A way of making Europe
European Regional Development Fund

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