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China’s National Medical Products Administration is gearing up to implement a unique device identification system and it has created a pilot program that will focus on high-risk implantable devices first. Read More
The FDA issued a warning letter to Polymer Technology Systems — doing business as PTS Diagnostics — arising from an inspection earlier this year of its facility in Indianapolis. Read More
The FDA is making new recommendations to manufacturers of duodenoscopes to transition to new designs that will eliminate the need for reprocessing. Read More
Russia’s Ministry of Health has rolled out new requirements for internal quality control and monitoring of the safety of devices in medical facilities. Read More
Houston-based medical devicemaker Talon received a lengthy FDA warning letter for design process and quality control issues following an inspection of the firm’s manufacturing facility. Read More
The International Medical Device Regulators Forum (IMDRF) has issued a new draft document on harmonizing terminology and codes for reporting adverse events for medical devices and in vitro diagnostics. Read More