AssurX Blog
Straight talk for regulated industries.
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 Dracula (or Miley Cyrus) costume and get some yucks faux scaring folks, the FDA is acting as a responsible pa [...]
FDA Proposals Take a Fresh Look at Some Stale Food Issues
That landmark Food Safety Modernization Act (FSMA) just keeps getting more and more important. Earlier this month, the FDA unveiled four proposed amendments that will likely make a tou [...]
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 media. Since then, the agency has issued an interesting warning letter to a Utah-based dietary supplement [...]
It’s Time to ‘Get’ IEC Before It ‘Gets’ You
Russ King, President, Methodsense FDA medical device recalls are on the rise. An increasingly active FDA, coupled with the rise in software components for medical devices is adding u [...]
FDA IDE Guidance Offers Industry Important Clarity
Michael Causey, Editor & Publisher, eDataIntegrityReport.com In its August 19 guidance for Investigation Device Exemption (IDE) Clinical Investigators, the FDA attempts to better [...]
Cybersecurity & Reliability Assurance Initiatives Top Priority at NERC Board Meetings
NERC held its Board of Trustees (BOT) and Member Representatives Committee (MRC) meetings in Vancouver, BC on August 13 – 14, 2014. The meeting included lively discussions on all the i [...]
