Hello! I’m Isabel. I have been working for more than 15 years to help companies, distributors and subcontractors of medical devices. Before being a consultant, I have seen the world from other angles; I have worked in Notified Bodies, and within the industry, in companies that manufacture medical devices.

Some years ago, I thought that all this experience could help others to face the arduous path of the regulation of medical devices. And thanks to clients who placed their trust in me, episKey Medical Consulting was born in 2019.

episKey Medical wants to work with clients who need a partner rather than a consultant.

We want to be by your side from the moment you start developing your product until it reaches the patients.

We would love to design your regulatory strategy, implement your quality system, decide with you the collaborators that will accompany you in the process. We want to share our experience so that your company obtains its objectives in the fastest way and with the highest quality.

We want to work with you because you are, like us, fast, creative, effective. Because we want to give you the opportunity to work with service providers in the medical device industry at the highest level worldwide.


About us

People with extensive experience in medical devices, and eager to collaborate. Accustomed to working in a changing and technological environment, we offer solutions to the Medical Devices industry adapted to your situation.

Why we want to work with you

Because we are as committed as you are to the health of patients. Because we know that it is not always easy to know all the regulations that accompany the process of placing a medical device on the market... and because we want to be close to Medical Organizations in this process. We will be for you a collaborator more than a consultant!.

Why we are experts

We know the international and European regulations on medical devices. Our experience comes from having worked with technology companies and medical start-ups. We know all the requirements that you must meet and how to meet them. We design strategies to market, import, export or distribute medical devices from the regulatory and quality point of view. For this, we count on you, your resources and your knowledge from the beginning, and, together with ours, we can achieve the strategy that is always the best for your company.