ISO 22442 : Medical Devices containing Animal Tissues and Derivatives
Medical device containing substances or tissues derived from animals are important class of devices and they are highly regulated according…
SOP of SOP
SOP – Standard Operating Procedure – are at the basis of any quality management system, independently from the business of…
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…
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…
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…
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…
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…
Implantable Medical Devices and related EU MDR Requirements
Implantable medical devices are usually highly risky devices for which a potential failure may cause serious consequences to the patient.…
Custom made Devices according to EU MDR 2017/745
The concept of custom-made devices is surely not new and many competent authorities have specific requirements in place to regulate…
General Safety and Performance Requirements (GSPR)
Several new requirements and topics have been introduced in medical device regulations, emphasizing the importance of specific minimum essential product…
