UDI Requirements for EU MDR and IVDR
The introduction of the UDI system for the medical device business can be considered a revolution and now the MDR and IVDR will soon be fully implemented, it is necessary
Equipment Maintenance: ISO 13485 Requirements
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
Information Security Management System Policy
The Information Security Management System Policy is one of the ket document for an efficient management of information security and to reach adequate level of compliance against ISO 27001. We
The PDCA Approach: Plan, Do, Check and Act
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
Legacy Devices and EU MDR Requirements
In this specific moment where the new EU MDR 2017/745 is officially entered into force, the management of the so-called legacy devices play a fundamental role from regulatory standpoint. In this
