AssurX Blog
Straight talk for regulated industries.
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 Unique Device Identification Database (GUDID) offline until it was ab [...]
US Drug Shortage Hits Patients, Pharmacies the Hardest
Patrick Stone, President, TradeStoneQA The corner drug store is not currently affected by many drug shortages. Instead, the pain is being inflicted on a vulnerable group of patients [...]
Cybersecurity – A Real Threat to Medical Devices
The FDA just issued a Safety Communication on cybersecurity vulnerabilities of the Hospira Symbiq Infusion System. The Hospira Symbiq Infusion System is a computerized pump designed fo [...]
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) report designed to shed light on what impact the medical devic [...]
Audit Management: the Perennial EQMS Straggler
AssurX has been in the business of configuring and implementing Enterprise Quality Management Solutions for two decades. Over that time, it has been a consistent finding that audit ma [...]
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 many House and Senate members lined up on one side determined to [...]
