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Expert perspectives that simplify complexity and support stronger quality and compliance outcomes.
FDA’s New 510(k) Guidance Emphasizes Software as Device Factor
The path to medical device commercialization requires FDA approval, which most often means filing a pre-marketing notifi [...]
FDA Pilot Program Encourages Quarterly Malfunction Summary Filings
FDA will be taking applications starting Sept 1, 2015, looking for makers of class I and suitable class II medical devic [...]
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 [...]
