Category: Post Market Surveillance
Finally got my copy of this interesting book on grey literature, which has great impact on medical device regulatory compliance. One of the definitions of grey literature is: “Grey literature stands for manifold document types produced on all levels of government, academics, business and industry in print and electronic formats that are protected by intellectual […]
Another series, initiated in a Linkedin post. The PMS process is nothing more than a research project focused on answering specific questions related to the product, with the objective of defining actions based on the research results. To do so, it must be planned and designed as a research project, with fundamental questions that the […]
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