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Clear, actionable intelligence for regulated industries.
Expert perspectives that simplify complexity and support stronger quality and compliance outcomes.
FDA’s UDI Initiative Continues to Roll Forward
Jeff Mazik, Vice President, Life Science Solutions, AssurX With the close of the 7th Annual UDI Conference in Baltimor [...]
Will New User Fees Fuel More FDA Inspections?
For FY 2016, FDA is requesting $4.9 billion to support our essential functions and priority needs, which is $425 million [...]
FDA Warning Letters Hit Device Makers Over CAPA, MDR Failures
It’s been a little while since we checked the FDA’s outgoing mail tray to find out what inspectors are looking for – and [...]
Medical Device Makers Express Optimism About Future – But QA Worries About US Regulatory Burden
Crystal may be clear, but crystal balls, at least metaphorically, are certainly not. The late, great political columnist [...]
FDA 510(k) Approval Process Now Averages Over Six Months
If you’ve got six months – and nerves of steel – here’s some good news: You have a 61% percent chance of getting your m [...]
FDA Issues Deadline Reminder to Medical Device Companies on Electronic Medical Device Reporting
Looks like it's crunch time for medical device manufacturers. Whether they submit one or 10,000 medical device reports [...]
