MDR Extension According to Regulation 2023/607
The extension of MDR implementation timeline has now become reality. On March 20, 2023, the Regulation (EU) 2023/607, which amends…
Quality Policy according to ISO 13485
The definition of the Quality Policy of the organization is one of the essential tasks associated to the top management…
How to write a Quality Manual fully compliant with ISO standards?
The quality manual is one of the most important documents for a company with a quality system in place, and…
What are the best Methods for Root-Cause Analysis ?
Performing an investigation in case any type of deviation occurs is of fundamental importance nowadays and root-cause analysis methodologies play…
Management Review
General Requirements It is important to demonstrate that top management reviews the suitability, adequacy and effectiveness of the organization’s quality…
Corrective and Preventive Actions (CAPA)
There is no doubt that CAPA (Corrective and Preventive Actions) is one of the most important process of any Quality…
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…
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…
Eudamed Database for Medical Devices in Europe: EU MDR requirements
The European Database on Medical Devices (EUDAMED) is an IT system developed by the European Commission to enhance the transparency,…
Statistic for Quality Management Systems: ISO and FDA Requirements
The use of statistic for activities related to quality management System is of great importance and both ISO 13485 and…