ISO 13485 audit is the methodology through which certification body performs the assessment of a quality system of an organization and issue the related ISO 13485 certificate, upon successful completion

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 Device History Record (DHR) is a specific set of documentation requested by the FDA Quality System Regulation; however nowadays it is something that is typically requested by any type

Quality agreement is one of the most important documentation in a context of medical device quality management system, including QMS requirements for EU MDR 2017/745.  The ISO 13485:2016 specifically requires to

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