IVDR New Guidance on Safety Reporting in Performance Studies
The Medical Device Coordination Group (MDCG) has recently publishe...
Responsibilities for Medical Devices Vigilance Reporting
Medical devices are regulated differently across the globe. Each c...
US FDA Traditional 510(K) Submission – A Step by Step Process
In the United States, medical devices are regulated under the Fede...
US FDA Medical Device Labeling Requirements
What Is Medical Device Labeling?
According to the FDA, medical dev...
Medical Devices Clinical Monitoring Best Practices
Effective Medical Device clinical trial monitoring is essential fo...
FDA Human Factors Engineering and Usability Guidelines
The FDA describes its requirements for human factors engineering i...
