Packaging Validation for Medical Devices
For medical devices that have to be provided sterile, packaging validation plays an extremely important role. The validation of the…
Clean Room Validation
Clean room validation is nowadays essential for medical device manufacturers of sterile devices; sterility of the devices has a direct…
Field Safety Corrective Actions : EU MDR Requirements
Field safety corrective action is one of the pillar process associated to post-market surveillance and its key importance is related…
Supplier Management and Regulatory Compliance: Key Aspects
Supplier management is a key aspect for any type of organizations, including medical device companies that often have to outsource…
IVDR 2017/746 : In Vitro Diagnostic Regulation
The IVDR – In vitro Diagnostic Regulation 2017/746 – will enter into force in 2022 but it is very important…
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…
