ICH Q9 : Quality Risk Management
ICH is the International Council for Harmonisation and deals with the harmanonization of technical requirements for pharmaceuticals for human use;…
Investigator’s Brochure According to EU MDR 2017/745
The investigator Brochure is a well known document needed to have the authorization to perform a clinical investigation study on…
Clinical Data Management
Medical devices are more and more used within clinical trial operations, especially in the last years with the huge development…
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…