QualityMedDev

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

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

In the last years, the reprocessing of medical devices started to play a critical role and additional requirements have been requested by competent authorities and regulators to ensure the safety