AssurX Blog
Straight talk for regulated industries.
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 infographic analysis, today's post highlights medical device warning l [...]
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 back at FDA's stats on various topics sourced from their Case fo [...]
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 expected, the FDA is shifting more and more of its regulatory fo [...]
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 submissions for your adverse event reports to the FDA, you might [...]
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, says an interesting new report from the California Healthcare Institute (CHI) an [...]
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 Global Unique Identifier Database (“GUDID”) since the rule’s effectiv [...]
