More information: Alexander O Everhart et al, Late adverse event reporting from medical device manufacturers to the US Food and Drug Administration: cross sectional study, BMJ (2025). DOI: 10.1136 ...

DUBLIN--(BUSINESS WIRE)--The "Latest Chinese Guidebook for Medical Device Adverse Events Reporting, Monitoring and Re-Evaluation" report has been added to ResearchAndMarkets.com's offering.

Nearly a third of medical device adverse events were not submitted to the FDA within a 30-day regulatory window, with most ...

A significant number of medical device adverse events that resulted in patient deaths were miscategorized in the FDA's Manufacturer and User Facility Device Experience (MAUDE) database ...

Adverse events are defined by the FDA as any undesirable experience associated with the use of a medical product in a patient. Once manufacturers or distributors become aware of device-related adverse ...

A bill introduced in Congress Wednesday would require doctors to report adverse events from medical devices to the U.S. Food and Drug Administration. The legislation, known as the "Medical ...

The Materiovigilance Programme of India (MvPI), under the Indian Pharmacopoeia Commission, has released the updated version of the medical devices adverse event reporting form, for the use of ...

Dublin, Nov. 03, 2022 (GLOBE NEWSWIRE) -- The "Medical Device Studies: Regulatory Requirements and Adverse Event Reporting Training Course" conference has been added to ResearchAndMarkets.com's ...

The goal is to improve patient safety by monitoring, recording, and analysing the root cause of adverse events or risks associated with the use of medical devices, including in-vitro-diagnostics.