Equipment maintenance according to ISO 13485 is one of the process described in the section 7 of the standard, and specifically in the section 7.6. The correct maintenance and calibration

The PDCA cycle stays at the base of any quality management system and it is an extremely important approach useful to fully understand the general structure of a quality

The requirements for customer related process are reported in the section 7.2 of the ISO 13485:2016. Customer related processes are highly linked with other processes of the quality system, such

Introduction In this post, we will go through the main requirements associated with the management representative role taking into consideration one main standard: ISO 13485 - Medical devices — Quality management systems

The version of 2016 of ISO 13485:2016 has a new requirement compared the previous version which is related to the so-called Medical Device File. The medical device file (MDF) is