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Expert perspectives that simplify complexity and support stronger quality and compliance outcomes.
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 F [...]
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 [...]
It’s Time to ‘Get’ IEC Before It ‘Gets’ You
FDA medical device recalls are on the rise. An increasingly active FDA, coupled with the rise in software components for [...]
FDA IDE Guidance Offers Industry Important Clarity
In its August 19 guidance for Investigation Device Exemption (IDE) Clinical Investigators, the FDA attempts to better o [...]
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 [...]
FDA Guidance Advises Device Makers to Think About Home-Use
Medical device manufacturers would be well-advised to address any potential risks associated with home-use products at t [...]
