QualityMedDev

The definition of the Quality Policy of the organization is one of the essential tasks associated to the top management according to ISO 13485 and other quality management system standards

ICH is the International Council for Harmonisation and deals with the harmanonization of technical requirements for pharmaceuticals for human use; among the different guidelines and regulations issued by ICH,

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