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 of "borderline" devices is huge. With QualityMedDev websites we have
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 to authorize the introduction on the US market of medical
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 it is something that is typically requested by any type
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 Diagnostic Regulation; this is why having a well documented clinical
