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 [...]
15
10, 2014
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 [...]
18
08, 2014
Cybersecurity & Reliability Assurance Initiatives Top Priority at NERC Board Meetings
NERC held its Board of Trustees (BOT) and Member Representatives Committee (MRC) [...]
13
08, 2014
FDA Guidance Advises Device Makers to Think About Home-Use
Michael Causey, Editor & Publisher, eDataIntegrityReport.com Medical devic [...]
5
08, 2014
FDA Spreads Regulatory Love Nationwide
Michael Causey, Editor & Publisher, eDataIntegrityReport.com Detroit may b [...]
29
07, 2014
Time to Take a Closer Look at FDA MDDS Moves
Russ King, Managing Partner, Methodsense The FDA recently released a new draft [...]
