Conformity Assessment for CE marking Process
The conformity assessment can be considered as the procedure through which compliance to the requirements of the MDR is demonstrated.…
Medical Device File according to ISO 13485:2016
The version of 2016 of ISO 13485:2016 has a new requirement compared the previous version which is related to the…
Clinical Evaluation according to EU MDR 2017/745
Clinical evaluation is the assessment and analysis of clinical data of a medical device to verify its clinical safety and…
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…