We tell you how our client, Medicsen, has recently obtained the license to manufacture medical devices, and has just announced that it has won the Fundación MAPFRE and IE Business School awards in the Health category....
We tell you everything you need to know about the regulation of medical devices for in vitro diagnostics....
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....
As a 100% women-owned company, we join in the celebration of International Women's Day....
The new regulation on medical devices is almost upon us. In May 2021 the Medical Device Regulation 745/2017 will enter into force. In order to facilitate the implementation process for medical device manufacturers, the European Commission has produced various documents on the different aspects covered...
Dicopt is the virtual reality technology for the treatment of lazy eye in children devised by our client V-Vision. The good news is that it has just been recognised as a registered medical device by the AEMPS. V-Vision, our client since March 2020, is the Spanish...
The Medical Devices and In Vitro Diagnostic Regulations (MDR 745/IVDR 746) have established a new role for manufacturers and their authorised representatives, if the manufacturer is not located in the EU. This is the "person responsible for regulatory compliance". This PRRC has certain obligations and...
In this blog we have discussed how to obtain a CE marking for your medical device in Europe. But what is the system like in the United States? This must be done through the Food and Drug Administration (FDA). This is the consumer protection agency...
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