Medical Device Reporting (MDR)
A requirement by the FDA that manufacturers, importers, and device user facilities report certain device-related adverse events and product defects.
October 27, 2025
A centralized resource hub dedicated to Medical Imaging and Radiology, providing extensive industry insights and a diverse collection of articles on essential topics. This platform aims to serve as an invaluable resource for healthcare professionals by delivering informative content on various imaging modalities, the latest advancements in radiological technology, best practices for patient care, and emerging trends in the field of medical imaging.
A requirement by the FDA that manufacturers, importers, and device user facilities report certain device-related adverse events and product defects.
The process of categorizing medical devices based on their level of risk, determining the regulatory requirements they must meet, such
A report documenting any deviations from established procedures or quality standards in the manufacturing or testing of medical devices.
An organization authorized by EU member states to assess the conformity of medical devices before they are marketed in Europe,
Ongoing monitoring of medical devices after they have been marketed, aimed at identifying any safety issues or adverse events to
The process of evaluating the clinical data of a medical device before it is marketed to ensure that it meets
The process through which medical device manufacturers notify regulatory agencies of their intent to market a device, including the submission
Laboratory-based testing conducted before a medical device or drug is tested on humans to assess its safety, effectiveness, and potential
The legal responsibility of manufacturers for any defects or malfunctions in their medical devices that cause harm or injury to
