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Clear, actionable intelligence for regulated industries.
Expert perspectives that simplify complexity and support stronger quality and compliance outcomes.
Audit Management: the Perennial EQMS Straggler
AssurX has been in the business of configuring and implementing Enterprise Quality Management Solutions for two decades [...]
Obama Veto Threat Looms Over Medical Device Tax Battle
Michael Causey, Editor-in-Chief,Association of Clinical Research Professionals With medical industry trade groups and [...]
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 [...]
