Category: Post Market Surveillance
EU postmarket surveillance plans for medical devices
From document – Summary of EU Member States and EEA EFTA States’ assessment and review of the functioning of market surveillance activities according to article 18(6) of Regulation (EC) No 765/2008 for the period 2014-2016
Some words from the US FDA about the duodenoscope problem, based on the post-market data : Statement from Jeff Shuren, M.D., J.D., Director of the Center for Devices and Radiological Health, on updated safety communication about rates of duodenoscope contamination from preliminary postmarket data Algumas palavras do US FDAsobre o problema dos duodenoscópios baseados nos dados […]
Continuing with the duodenoscope topic: Olympus Medical pleads guilty to failing to file events notice: Justice Department. Continuando com o tema do duodenoscópios: Olympus Medical pleads guilty to failing to file events notice: Justice Department.
This goes back to the ongoing duodenoscopes problems related to design and reprocessing… Isso remonta aos problemas relacionados ao design e reprocessamento de duodenoscópios…. The FDA Provides Interim Results of Duodenoscope Reprocessing Studies Conducted in Real-World Settings: FDA Safety Communication