ISO 18113 : Labelling Requirements for IVD Medical Devices
ISO 18113 defines the requirements associated to labelling for In-Vitro Diagnostic Medical Devices. We have extensively discusse about labelling in…
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…
MDCG : Medical Device Coordination Group
MDCG – Medical Device Coordination Group is a new entity that has been introduced with the EU Medical Device Regulation…
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…
Article 120 MDR: An Overview
We have already been discussing about the requirements associated to legacy devices, mentioning as well the existence of the Article…
Field Safety Notice: What do you Need to Know?
Field safety notice (FSN) is one of the main tool that can be implemented by a manufacturer to inform customers…
Electronic IFU (eIFU) for Medical Devices: Key Requirements
eIFU (electronic IFU) became more and more important in the last tears, due to the huge progress of digital health…
