Medicsen obtains medical device manufacturer’s licence and comes with a prize!

They are unstoppable! Our client Medicsen, which has recently obtained the license to manufacture medical devices, has just announced that it has won the Fundación MAPFRE and IE Business School awards in the Health category.

These awards first appeared in 2018 with the aim of “supporting and promoting innovative solutions to improve the world we live in” and have recognised the innovation and originality of the Medicsen Smartpatch. This device allows drug delivery, is fully portable and needle-free.

This product increases the size of the skin pores so that macromolecules such as heparin or insulin can enter the body safely and painlessly.

Medical device manufacturing authorisation

Medicsen has also developed a predictive algorithm for Type I diabetes. This software is able to predict the glucose levels a patient will have in the next few hours. In this way, the required dose of insulin, or the amount of food, can be adjusted.

The company has recently obtained a manufacturer’s licence for this glucose level prediction algorithm. This process is an achievement resulting from the collaborative work of EpisKey Medical Consulting S.L. and Medicsen. In this case, the technical manager, César de Mercado, the CTO, José Carlos Montesinos and the algorithm manager, Antonio Reche, have worked side by side with our software consultant, Bárbara Gómez-Tavira, in order to obtain the medical device manufacturer’s licence.

Who processes the medical device manufacturer’s licence?

The manufacturer’s licence is a document obtained through the Spanish Agency for Medicines and Health Products (Agencia Española del Medicamento y Productos Sanitarios) accrediting that the manufacturer can market its device or software as a medical device. The AEMPS has very clear and strict criteria on what it considers to be activities or companies that must apply for a prior operating licence and companies that are not subject to licensing.

The AEMPS shall verify that the manufacturing company has the necessary facilities, means, procedures and personnel to carry out the manufacturer’s activities. For this purpose, he will visit the facilities.

How to apply for a manufacturer’s licence?

First of all, it is necessary to gather the legal documentation relating to the manufacturing company, deeds, organisation chart… This is in addition to the product-related documents, such as the software development plan, the user manual, etc. And finally, a set of procedures must be provided to explain how all the company’s processes are carried out.

Once all the documents have been collected, they must be classified according to the guidelines established by the AEMPS in the application developed for this procedure.

For EpisKey Medical Consulting S.L., the preparation of these documents is the first contact with the products and helps us in our aim to get to know our clients’ activities perfectly.



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