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

What are Common Specifications? The definition of common specifications according to the EU MDR and  IVDR is “ set of technical and/or clinical requirements, other than a standard, that provides

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

SAMD - Software As Medical Device became more and more spread within the healthcare. The worldwide spread of software applications pushed the regulators to include in medical device regulations specific

Traceability for Software Validation Activities  In the framework of software validation, it is of fundamental importance to maintain full traceability during the whole entire project and in this context the requirement