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 ISO standard...
¡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...
Restrictions adopted due to the coronavirus pandemic are gradually being relaxed. The options to participate in face-to-face meetings are increasing. Through Ticbiomed, we are informed of the call for the Forum on Innovation and Digital Transformation in Health for March 16 in Murcia. At Episkey...
Our Operations Director, Sandra Javaloyas, has published, in the February 2022 issue of Farmespaña Industrial magazine, an article about what Combination Products are and what regulation affects them. The regulation of Combined Products can be very complicated and sometimes help is needed to understand them as...
¡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 Body does not...
The year 2022 has started with a leap in the participation of informative and, above all, teaching activities. Episkey Medical Consulting has participated in two online events that have helped in the understanding of healthcare regulation. Master's Degree in Biomedical Technology Management and Development On 10 February,...
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...
The first programme of Universo regulación, a podcast produced by Episkey Medical Consulting, is now available. We want to help you understand the world of regulatory issues affecting medical devices, their manufacturers and distributors. This first podcast is dedicated to generalities, our CEO, Isabel López Guerrero, talks...
We explain how to obtain the UKCA Mark for medical devices after the entry into force of the MHRA regulation....
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