ISO 13485 Audit
ISO 13485 audit is the methodology through which certification body performs the assessment of a quality system of an organization…
Medical Devices | Information Security | Artificial Intelligence
ISO 13485 audit is the methodology through which certification body performs the assessment of a quality system of an organization…
In this short article we will go through the requirements related to mandatory documents for ISO 13485, especially in relation…
The Device History Record (DHR) is a specific set of documentation requested by the FDA Quality System Regulation; however nowadays…
Quality agreement is one of the most important documentation in a context of medical device quality management system, including QMS…
The definition of the Quality Policy of the organization is one of the essential tasks associated to the top management…
Equipment maintenance according to ISO 13485 is one of the process described in the section 7 of the standard, and…
The PDCA cycle stays at the base of any quality management system and it is an extremely important approach useful…
The requirements for customer related process are reported in the section 7.2 of the ISO 13485:2016. Customer related processes are…
Introduction In this post, we will go through the main requirements associated with the management representative role taking into consideration…
The version of 2016 of ISO 13485:2016 has a new requirement compared the previous version which is related to the…