MDCG Issues Guidance on Investigator’s Brochure for Medical Device Studies
The Medical Device Coordination Group (MDCG) is a regulatory body...
IVDR New Guidance on Safety Reporting in Performance Studies
The Medical Device Coordination Group (MDCG) has recently publish...
Responsibilities for Medical Devices Vigilance Reporting
Medical devices are regulated differently across the globe. Each ...
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...
Medical Devices Clinical Monitoring Best Practices
Effective Medical Device clinical trial monitoring is essential f...