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Clear, actionable intelligence for regulated industries.
Expert perspectives that simplify complexity and support stronger quality and compliance outcomes.
Are You Ready for 21st Century eMDR Submissions?
Jeff Mazik, Vice President, Life Science Solutions, AssurX If you have been procrastinating on setting up electronic s [...]
Report: Medical Device Approval Still Lags, but FDA is Trying
After years of decline, the speed of FDA device approvals has finally begun to hit the gas pedal a bit. This is accordin [...]
FDA Applauds GUDID Progress, Eyes Class II Compliance Efforts
The Food and Drug Administration (FDA) reported that there have been over 240 user accounts set up in the agency’s Globa [...]
FDA Works to Soothe Industry at Medical Device Cybersecurity Webinar
The FDA will focus more on a device maker's overall approach to ensuring cybersecurity rather than burrowing down and ki [...]
FDA Warning Letter Analysis: CAPA, CAPA, and More CAPA!
After a flurry of activity, it's been relatively quiet of late on the FDA warning letter front. But three device makers [...]
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 [...]
