Medical Device Definition according to EU MDR 2017/745
Medical Device definition has been changed with the new EU MDR 2017/745 and the impact of this change over manufacturers…
Overview of the 510k Process
One of the most important regulatory submission processes for medical device manufacturers is the so-called 510k submission, used by FDA…
Device History Record (DHR): An Overview
The Device History Record (DHR) is a specific set of documentation requested by the FDA Quality System Regulation; however nowadays…
Clinical Evaluation Plan according to EU MDR 2017/745
There is no doubt about the central role of clinical evaluation in relation to the European Medical Device and in-vitro…
