Hemocompatibility is on of the test requested to assess the safety of a medical devices that come in contact with blood. It is obvious that among the whole set of

The understanding and implementation of the regulatory requirements in the early stages of the product life cycle will ensure and adequate development of the medical product under development.  The definition of

The IEC 60601 has played and still currently plays a key role for safety of active medical devices. The IEC 60601 is basically a group of standards which is dealing

In this article we will go through the requirements associated to Software Architecture according to IEC 62304:2006/AMD-1:2015. The IEC 62304 is the standard that described the documentation associated to life

In the framework of the process of Design and Development, the design transfer (DT) corresponds to the last phase, where the specifications are basically transferred to the manufacturing environment to