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 | Ene 28, 2022 | Uncategorized
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...
por Paloma Lopez | Ene 24, 2022 | Uncategorized
On 1 January 2021, the post-Brexit transition period came to an end, meaning that the United Kingdom has now been outside the European Union for a year, which brings us closer to the official entry into force of the UKCA (United Kingdom Conformity Assessment). The...
por Paloma Lopez | Oct 14, 2021 | Uncategorized
On 14 October, the European Commission proposed a postponement of the entry into force of the IVDR Regulation, which was due to enter into force on 26 May 2022. This request follows a report issued by MedTech Europe which surveyed IVD product manufacturers, showing...
por Paloma Lopez | Sep 1, 2021 | Uncategorized
The European Commission has just published the date for the entry into force of the new regulation on clinical trials for medicinal products, Regulation 536/20/EC; it will be 3 January 2022. This has given us an opportunity to discuss what standards and procedures...
