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,

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

The benefit risk analysis is one of the key elements of the risk management process for medical devices and, more in general, a key element for any quality system. We

It is impossible to deny the importance of risk management process for medical device organization and the recent publication of the updated version of ISO 24971 is a valuable tool

The risk management plan is one of the key document for the risk management process for a medical device manufacturers and it is essential to understand the requirements that are