Software Architecture according to IEC 62304
In this article we will go through the requirements associated to Software Architecture according to IEC 62304:2006/AMD-1:2015. The IEC 62304…
Common Specifications according to EU MDR 2017/745
What are Common Specifications? The definition of common specifications according to the EU MDR and IVDR is “ set of…
The Risk Benefit Analysis
The benefit risk analysis is one of the key elements of the risk management process for medical devices and, more…
Software as Medical Device (SaMD) : What Do you Need to Know?
SAMD – Software As Medical Device became more and more spread within the healthcare. The worldwide spread of software applications…
Requirements Traceability Matrix
Traceability for Software Validation Activities In the framework of software validation, it is of fundamental importance to maintain full traceability…
Design Transfer: A practical Approach
In the framework of the process of Design and Development, the design transfer (DT) corresponds to the last phase, where…
ISO 17664: Processing Instructions for Medical Devices
In the last years, the reprocessing of medical devices started to play a critical role and additional requirements have been…
