por Paloma Lopez | Feb 18, 2022 | Uncategorized
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...
por Paloma Lopez | Feb 14, 2022 | Regulación
Hoy lanzamos el segundo episodio de Universo Regulación, el podcast producido por Episkey Medical Consulting para ayudar a los fabricantes, importadores y distribuidores de productos sanitarios. En este episodio Isabel nos explica qué es una auditoría y Victoria nos...
por Paloma Lopez | Feb 14, 2022 | Uncategorized
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...
por Paloma Lopez | Feb 4, 2022 | Uncategorized
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,...
por Paloma Lopez | Feb 4, 2022 | Regulación
El reglamento MDR 2017/745 sobre los productos sanitarios, especifica claramente qué requisitos deben cumplir las investigaciones clínicas para que sean aportadas como evidencia clínica en la evaluación clínica que se redacta para obtener un marcado CE. En concreto,...
