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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
There has been a steady uptick in the number of FDA 483s that cite inadequate supplier controls — from 84 in 2011, to 110 in 2012 and 126 last year. Read More
Manufacturers should update their medical device tracking procedures to account for unique device identifiers, the FDA says in updated guidance. Read More
Molecular diagnostics company Biocept now offers clinical trial and drug development support services for targeted therapeutics, the company said Monday. 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