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TriMed, a maker of implantable bone fixation systems, failed to report a device failure that required surgery to remove the device, according to an FDA warning letter. Read More
Device manufacturers will have an opportunity to sit down with the FDA to hear its perspective on the Quality Metrics Initiative during the Case for Quality Public Forum Oct. 26. Read More
Failure to submit medical device reports for its total parenteral nutrition bags landed the Metrix Company an eight-item Form 483 following a May 2016 inspection of its Dubuque, Iowa facility. Read More
One of the most important considerations device manufacturers will make before entering China is whether the device will be manufactured locally or not. Read More
The FDA handed a warning letter to Tosoh Bioscience, an importer of assays and high performance liquid chromatographs, for failing to properly manage its suppliers and handle complaints. Read More
Poor supplier controls remain one of the top five FDA citations for device manufacturers, and with outsourcing continuing to grow, supplier networks can become a complicated web to manage. Read More
The FDA plans to unveil by Oct. 1 its own quality metrics for devicemakers based on three metrics from a pilot program conducted by Xavier Health and the Medical Device Innovation Consortium. Read More
Japan’s Mitaka Kohki failed to establish design control procedures, CAPA procedures, equipment calibration procedures, and documentation was found lacking for numerous critical processes during an inspection of the Tokyobased facility. Read More