ISO 23640: Stability Evaluation for IVD Medical Devices
For in-vitro diagnostic devices, ISO 23640 plays a key role as it defines the requirements related to the stability of in-vitro diagnostic reagents used within an IVD devices. We have
MDCG : Medical Device Coordination Group
MDCG - Medical Device Coordination Group is a new entity that has been introduced with the EU Medical Device Regulation 2017/745 and In-vitro Diagnostic Regulation 2017/746. The MDCG takes part
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
