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 to the impact of this process to the safety of
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 manufacturing operations or other type of activities. From regulatory standpoint, ISO
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 to discuss since now the changes that this new regulation
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 is the standard that described the documentation associated to life
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 technical and/or clinical requirements, other than a standard, that provides
