Sterilization Regulatory Requirements and Supporting Standards
Sterilization of medical devices is a critical process integral to...
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...
In Vitro Diagnostic Regulation (IVDR) – General Aspects, Key features and Limitations
Introduction to IVDR:
The In Vitro Diagnostic Regulation (IVDR) re...
Medical Devices Clinical Monitoring Best Practices
Effective Medical Device clinical trial monitoring is essential fo...
