Universo Regulación

Universo Regulación

Our Universo Regulación is back, the podcast that talks about medical devices and how they are regulated. In this programme, Isabel talks about the importance of being clear about what the acronyms of international standards stand for. We explain why complying with an...
¡New programme of Universo Regulación!

¡New programme of Universo Regulación!

¡New programme of Universo regulación! We talked to Isabel about what an in vitro diagnostic medical device is and how these special products are regulated. He tells us that these are products that do not come into contact with the patient himself, but with a sample...
New programme of Universo regulación

New programme of Universo regulación

¡New programme of Universo regulación! Isabel tells us about the certification process. What types of actors and agencies are involved? For a product to be marketed, 3 actors come into play: Manufacturer, AEMPS and, possibly, ON. Because it may be that the Notified...