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FDA FastStats: A Look Back at 2013 Medical Device Warning Letters with Quality System Deficiencies
FDA FastStats: A Look Back at 2013 Medical Device Warning Letters with Quality System Deficiencies: In our latest infogr [...]
FDA FastStats: A Look Back at 2013 Medical Device 483 Observations
FDA FastStats: A Look Back at 2013 Medical Device 483 Observations: As we approach the end of 2014, we will take a look [...]
FDA’s Local Offices Flex Regulatory Muscle
In our latest round-up, it was the District Offices turn to chime in on medical device company alleged shortcomings. As [...]
Are You Ready for 21st Century eMDR Submissions?
Jeff Mazik, Vice President, Life Science Solutions, AssurX If you have been procrastinating on setting up electronic s [...]
Report: Medical Device Approval Still Lags, but FDA is Trying
After years of decline, the speed of FDA device approvals has finally begun to hit the gas pedal a bit. This is accordin [...]
FDA Applauds GUDID Progress, Eyes Class II Compliance Efforts
The Food and Drug Administration (FDA) reported that there have been over 240 user accounts set up in the agency’s Globa [...]
