For medical devices released by the manufacturer in a sterile form, one of the main principles that assure quality, safety and efficiency is the use of a package that provides maintaining of the medical device characteristics in the process of transportation and storage within [...]

In this article, we’ll try to consider various aspects of validation of software for medical devices. Nowadays, more and more medical devices that are being entered into the market includes software or are represented by a program product without hardware components. These medical devices, [...]

What is nomenclature classification of medical devices by types and what is needed for Each medical device registered on the territory of the Russian Federation should belong to a specified type according to nomenclature classification of medical devices. In fact, the nomenclature type of the [...]