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All devicemakers holding CE certificates for Class IIa medical devices and higher should be prepared for unannounced quality system visits by notified body inspectors. Read More
Clinical Director Pattanam Srinivasan, of the Advanced Interventional Pain Center, received an FDA warning for serving simultaneously as a study sponsor, clinical investigator and the head of the AIPC institutional review board. Read More
A group of FDA task forces Tuesday recommended that the agency expand the amount of information it releases on inspections and enforcement, allowing the public to view a more detailed record of a company’s compliance history. Read More
Overall reports of adverse events declined over the past three years from 21,729 in 2011 to 14,819 in 2013, according to data published by the UK’s Medicines and Healthcare products Regulatory Agency. Read More
DexCom, a San Diego maker of continuous glucose monitors, has been warned over medical device reporting failures and problems with its MDR procedure. Read More
LumiQuick Diagnostics received an FDA warning letter after an investigator saw employees assembling a drugs of abuse test panel and an amphetamine test strip on the same table. Read More
Devicemakers saw an increase in 2013 in the number of FDA 483s that cite inadequate supplier controls; the finding is now one of the top five most common 483 findings for devicemakers. Read More
The International Medical Device Regulators forum will immediately suspend auditing organizations from the Medical Device Single Audit Program if there is evidence of any wrongdoing during a facility audit. Read More