Today we launch the second episode of Universo Regulación, the podcast produced by Episkey Medical Consulting to help manufacturers, importers and distributors of medical devices. In this episode Isabel explains what an audit is and Victoria brings us the classification of medical devices. We also talk...

The MDR 2017/745 regulation on medical devices clearly specifies the requirements that clinical investigations must meet in order to be submitted as clinical evidence in the clinical evaluation that is drafted to obtain a CE marking. In particular, in its Chapter VI, it explains that...

There are already 1000 people who follow EpisKey on social networks and who are up to date with all the publications that we launch to better understand what this world is like....

If you manufacture, distribute or have had an idea for a product or software in the health field, you should know whether it is a medical device. Given the large number of definitions in circulation, it is worth considering the one offered by the Spanish Agency...

We tell you what steps you need to take to find out what your medical device looks like, what risk class it falls into and what technical documentation you need to prepare....

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