Descripción: “...The development of specific standards for each particular medical team is not easy, so it is important that all equipment functionality in the area of medicine before going to the market or already being in it, have an analysis to verify correct operation in order to protect and improve the quality of life, not only in patients, but also of all who are in constant contact with them.This article presents a methodology for designing validation protocols to medical technology; starting with a review of the rules and procedures applicable for international certification by FDA or INVIMA at national level; It is followed by a search of companies or laboratories that can perform the necessary tests and the design of protocols and checklists, for this, a series of tests on medical devices in order to check compliance with the standards set will be developed by different agencies responsible for monitoring and regulation of medical devices. ...”

Descripción: “...The increase of data creation is further catalysed by new technologies and connected devices; it is often referred to as the “internet of things” or “IoT-devices”. ...”

Descripción: “...One of the operational risks to which a Health Care Provider (HCP) is exposed is the receiving and use of products such as pharmaceuticals and medical devices that could become subject to a health alert. ...”