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…
Hemocompatibility of Medical Devices: an Overview
Hemocompatibility is on of the test requested to assess the safety of a medical devices that come in contact with…
Free Sale Certificate according to EU MDR
The free sale certificate is an essential document to expert medical devices. These are certificates that are aiming at facilitating…
Product Life Cycle for Medical Devices
The understanding and implementation of the regulatory requirements in the early stages of the product life cycle will ensure and…
Harmonised Standards and EU MDR 2017/745
Harmonised standards (HS) play a pivotal role in the European Union’s regulatory framework for medical devices, particularly under Regulation (EU)…
