Got Safe Beef? New Report Suggests the US Doesn’t
FSMA: Got Safe Beef? New Report Suggests the US Doesn't: The next time you want [...]
9
12, 2014
3
12, 2014
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 S [...]
25
11, 2014
FDA FastStats: A Look Back at 2013 Medical Device 483 Observations
FDA FastStats: A Look Back at 2013 Medical Device 483 Observations: As we approa [...]
24
11, 2014
FDA’s Local Offices Flex Regulatory Muscle
In our latest round-up, it was the District Offices turn to chime in on medical [...]
21
11, 2014
Are You Ready for 21st Century eMDR Submissions?
Jeff Mazik, Vice President, Life Science Solutions, AssurX If you have been pr [...]
5
11, 2014
Report: Medical Device Approval Still Lags, but FDA is Trying
After years of decline, the speed of FDA device approvals has finally begun to h [...]
31
10, 2014
FDA Applauds GUDID Progress, Eyes Class II Compliance Efforts
The Food and Drug Administration (FDA) reported that there have been over 240 us [...]
30
10, 2014
FDA Works to Soothe Industry at Medical Device Cybersecurity Webinar
The FDA will focus more on a device maker's overall approach to ensuring cyberse [...]
15
10, 2014
FDA Warning Letter Analysis: CAPA, CAPA, and More CAPA!
After a flurry of activity, it's been relatively quiet of late on the FDA warnin [...]
1
10, 2014
Medical Device Cybersecurity Risks Are The Wrong Kind of Halloween Fright
Well, Halloween is approaching boys and girls. And while it's fun to don a Dracu [...]
