por Isabel | Dic 21, 2020 | Uncategorized
One of the novelties we are offering this month for our customers is assistance in obtaining a certificate of free sale for the export of a medical device. What are they? How are they obtained? we have prepared a post where we explain it to you. What is a certificate...
por Isabel | Nov 6, 2020 | Uncategorized
We are currently witnessing a change in the regulation of medical devices. The current Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/ECC) will be replaced by the European Medical Devices Regulation 2017/745 (MDR) in May...
por Isabel | Oct 29, 2020 | Blog EN, Uncategorized
Congratulations! Our client 2EyesVision has just announced that it has been awarded ISO 9001:2015 certification. This achievement is the result of the collaborative work of EpisKey Medical Consulting S.L. and 2EyesVision, a laborious process in which Diana Martín, the...
por Isabel | Jul 20, 2020 | Uncategorized
Machine learning applied to medical devices In the world of medical devices we are witnessing a phenomenon that describes “knowledge transfer”. It is the transition from a technology developed in a purely scientific research environment to its application...
por Isabel | Feb 3, 2020 | Blog EN, Uncategorized
(Information update: Brexit and medical devices) Manufacturers of medical devices and medicines who are interested in finding out what the relationship between the European Union and the United Kingdom will be like after Brexit have at their disposal a publication...
por Isabel | Ene 23, 2020 | Blog EN, Uncategorized
Eudamed, the forthcoming medical device information database developed by the European Commission, already has a guide to clarify the nomenclature-related requirements to be met by manufacturers. The guide consists of two documents: A document covering the European...
