Medical Devices Regulation Expertise

The best way to ensure that medical devices meet international regulatory requirements is through a consulting service.

In EpisKey Medical Consulting we work with a team of specialists with extensive experience in medical devices, and eager to collaborate. We carry out projects that deal with obtaining the distribution license 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, authorizations, regulations, certifications, etc.