The quality manual is one of the most important documents for a company with a quality system in place, and in particular if the company is ISO 13485 certified. ISO

Performing an investigation in case any type of deviation occurs is of fundamental importance nowadays and root-cause analysis methodologies play a fundamental role within the regulated environment. Events and Casual

General Requirements It is important to demonstrate that top management reviews the suitability, adequacy and effectiveness of the organization’s quality system at defined intervals and with sufficient frequency. This is to

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

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