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,

ISO 13485 FDA ISO 13485 and FDA: Harmonization with FDA QSR and insights on next version of ISO 13485 In this paragraph we want to discuss about the future integration between ISO

Introduction: Cybersecurity Requirements and EU MDR 2017/745 In the last decade, the role of cybersecurity substantially increased in the medical device sector; new guidelines to define cybersecurity requirements appeared, first by

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