Post-Market Surveillance for EU MDR
New Requirements for Post-market Surveillance The EU MDR 2017/745 and IVDR 2017/746 provides a big revolution for post-market surveillance, with a new framework of requirements which need to be implemented for
ISO 10993-1 : Biocompatibility Evaluation for Medical Devices
Biocompatibility evaluation according to ISO 10993-1 and the related biological risk assessment is one of the most important validation activities for medical device. It is an important process during the
ISO 20416:2020 – Post-Market Surveillance for Medical Device.
The role of post-market surveillance for medical device manufacturers became more and more important. In this post we give an overview to ISO 20416:2020, a new technical standard with the
Design History File (DHF): An Overview
Design History File (DHF) for Medical Devices: Introduction This posts wants to provide an overview of the process of preparation of the design history file (DHF) for medical devices according to
Computer System Validation
Introduction Computer System Validation (CSV) is an extremely important subject for Quality Management System of highly regulated companies; software . In fact, every company focusing on medical device or pharmaceutical business
