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FDA investigators conducting quality system inspections are becoming a more common sight at international facilities, according to new numbers unveiled last week by the agency’s device center. Read More
With an eye toward ensuring patient safety, Malaysia’s Medical Device Authority has provided its thinking on how companies should report incidents involving medical devices. Read More
Olympus America, Fujifilm Medical Systems and Pentax’s Hoya unit had to submit postmarket surveillance studies to the FDA detailing how their duodenoscopes are reprocessed in healthcare facilities. Read More
Russia’s device authority is taking a strong stance against counterfeit and unregistered products, according to representatives at separate events in November. Read More