For any type of quality management system, whether within the medical device sector or not, having an established document control process and procedure it is essential. The quality system is

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. We have already been