The Role of Clinical Monitoring in the Success of Medical Device Trials in the USA
Clinical monitoring is an indispensable component of the medical ...
US FDA Traditional 510(K) Submission – A Step by Step Process
In the United States, medical devices are regulated under the Fed...
US FDA Medical Device Labeling Requirements
What Is Medical Device Labeling?
According to the FDA, medical de...
In Vitro Diagnostic Regulation (IVDR) – General Aspects, Key features and Limitations
Introduction to IVDR:
The In Vitro Diagnostic Regulation (IVDR) r...
Technical Documentation Best Practices for EU MDR
Manufacturers shall ensure the conformity of medical devices bein...
Differences between US FDA and EU MDR Usability Studies requirements
Regulatory frameworks for usability testing
IEC 62366-1:2015 is a...