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...
FDA Human Factors Engineering and Usability Guidelines
The FDA describes its requirements for human factors engineering i...
Technical Documentation Best Practices for EU MDR
Manufacturers shall ensure the conformity of medical devices being...
High Level Approach for PMCF Activities
The Medical Devices field is a constantly moving area. Several dev...
