Category: Post Market Surveillance

Grey literature and medical devices

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 […]

Creating a post market surveillance (PMS) system for medical devices – Part 1

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 […]

USFDA – Statement about rates of duodenoscope contamination from preliminary postmarket data

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 […]