The investigator Brochure is a well known document needed to have the authorization to perform a clinical investigation study on a medical device, in order to evaluate its safety and

Medical devices are more and more used within clinical trial operations, especially in the last years with the huge development of digital medical device technologies; in this context, clinical data

Medical device containing substances or tissues derived from animals are important class of devices and they are highly regulated according to specific ISO standards, the ISO 22442 family of standards.  Obviously

SOP - Standard Operating Procedure -  are at the basis of any quality management system, independently from the business of the organization. The can be defied as “ set

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