MDCG 2020-8 Post-market clinical follow-up (PMCF) Evaluation Report Template. A guide for manufacturers and notified bodies
Posts published in “Post Market Surveillance”
MDCG 2020-7 Post-market clinical follow-up (PMCF) Plan Template. A guide for manufacturers and notified bodies
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…
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…
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…
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…
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…
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…