There is no doubt that CAPA (Corrective and Preventive Actions) is one of the most important process of any Quality Management System based on ISO 13485:2016. We have already been

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

Insights into the ISO 13485 certification process for Quality Management System. ISO 13485 certification is the process to certify that a quality management system is able to ensure quality,

Eudamed is a database that will be used to monitor both the safety and performance of medical devices distributed in Europe and it has been introduced in parallel with the

The use of statistic for activities related to quality management System is of great importance and both ISO 13485 and FDA regulation have specific requirements. This is done to ensure