Hello! I am Isabel. For more than 15 years I have been helping companies, distributors and subcontractors of medical devices. Before becoming a consultant, I worked for Notified Bodies and medical device manufacturers. With this experience I founded Episkey Medical Consulting in 2019.
EpisKey Medical works with clients who need a partner rather than a consultant. We want to be by your side from the moment you start developing your healthcare productuntil it reaches patients.
We would be happy to design your regulatory strategy, implement your quality system and decide with you on the partners who will accompany you in the process. We want to share our experience so that your medical device manufacturing company achieves its objectives in the fastest way and with the highest quality.
At EpisKey Medical Consulting we work with a team of specialists with extensive experience in medical devices, and with a great desire 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 equipment 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.
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