Are You Ready for 21st Century eMDR Submissions?
Jeff Mazik, Vice President, Life Science Solutions, AssurX If you have been pr [...]
21
11, 2014
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 [...]
24
09, 2014
FDA Proposals Take a Fresh Look at Some Stale Food Issues
That landmark Food Safety Modernization Act (FSMA) just keeps getting more and m [...]
17
09, 2014
The FDA is Reading Your Facebook Page and They Don’t ‘Like’ What They See
In a previous post we looked at the FDA's relatively ho-hum guidance on social m [...]
15
09, 2014
It’s Time to ‘Get’ IEC Before It ‘Gets’ You
Russ King, President, Methodsense FDA medical device recalls are on the rise. [...]
26
08, 2014
FDA IDE Guidance Offers Industry Important Clarity
Michael Causey, Editor & Publisher, eDataIntegrityReport.com In its August [...]
