BLOG
Clear, actionable intelligence for regulated industries.
Expert perspectives that simplify complexity and support stronger quality and compliance outcomes.
FDA Takes GUDID Offline: Security breach? Or Proactive Measures?
FDA detected a "security vulnerability" earlier this month that spooked it enough to take the highly-touted Global Uniqu [...]
US Drug Shortage Hits Patients, Pharmacies the Hardest
Patrick Stone, President, TradeStoneQA The corner drug store is not currently affected by many drug shortages. Instea [...]
Cybersecurity – A Real Threat to Medical Devices
The FDA just issued a Safety Communication on cybersecurity vulnerabilities of the Hospira Symbiq Infusion System. The H [...]
GAO Report Finds Steady Medical Device Profit Climb – Especially the Big Boys
Michael Causey, Editor-in-Chief,Association of Clinical Research Professionals A new Government Accounting Office (GAO [...]
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 [...]
