ISO 13485 Mandatory Documents
In this short article we will go through the requirements related to mandatory documents for ISO 13485, especially in relation…
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…
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…
ISO 13485 and the FDA : The Future of Quality Management Systems
ISO 13485 and FDA: Harmonization with FDA QSR and insights on next version of ISO 13485 In this paragraph we…
Cybersecurity Requirements for Medical Devices and EU MDR 2017/745
Introduction: Cybersecurity Requirements and EU MDR 2017/745 In the last decade, the role of cybersecurity substantially increased in the medical…
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…