In this short article we will go through the requirements related to mandatory documents for ISO 13485, especially in relation to procedure, and we provide evidence of how QualityMedDev can

The definition of the Quality Policy of the organization is one of the essential tasks associated to the top management according to ISO 13485 and other quality management system standards

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

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