The device master record is a design document specifically requested by the FDA Quality System Regulation, as per 21 CFR 820.181. If we follow the definition reported in the regulation:

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

ISO 62366 plays a fundamental role in the design process for medical device as it explains the requirements related to usability. Usability studies are an essential part of the design

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. First of all there

Introduction Computer System Validation is an extremely important subject for Quality Management System of highly regulated companies. In fact, every company focusing on medical device or pharmaceutical business needs to perform

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