The Role of Economic Operators within the EU MDR 2017/745
Who are Economic Operators according to EU MDR? The term Economic Operators is explained in article 2 of EU MDR…
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…
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…
ISO 20416:2020 – Post-Market Surveillance for Medical Device.
ISO 20416 post market surveillance
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…
Computer System Validation
Introduction Computer System Validation (CSV) is an extremely important subject for Quality Management System of highly regulated companies; software .…
FDA meets Digital Health Devices: the Pre-Cert Program
FDA Digital Health Devices Regulation – Pre-Cert Program FDA has launched the so-called Software Pre-Cert Program. The goal is to…
New ISO 14155:2020 Clinical Investigation for Medical Devices
Very recently, ISO published a new version of ISO 14155:2020 – Clinical investigation of medical devices for human subjects —…
ISO 15223-1:2021 : New Symbols for Medical Devices
ISO 15223-1:2021 new symbols for medical devices In this paragraph, we will talk about the update of ISO 15223-1 that…
What is ISO 13485 quality management system
Insights into the ISO 13485 certification process for Quality Management System. ISO 13485 certification is the process to certify that…
