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Medical Device Manufacturers Warned For CAPA Non-Compliance
Three recent warning letters from the Center for Device and Radiological Health (CDRH) offer a glimpse into ongoing medi [...]
Disciplined Patch Management is Essential: Take Note from the Energy Industry
The massive global cyber-attack on May 12 demonstrated a large lesson regarding disciplined patch management. The aggres [...]
FDA Enforcement Trends: Pharmaceutical Manufacturing Quality Focus
After a bit of a lull, the U.S. Food and Drug Administration (FDA) issued a batch of warning letters focused on pharmace [...]
How Will Real-World Evidence Impact 2017 FDA Guidances?
The Advanced Medical Technology Association (AdvaMed) wants the Food and Drug Administration (FDA) to understand that m [...]
CDRH Report: Quality Management Insights For Medical Device Manufacturers
FDA's Center for Devices and Radiological Health (CDRH) provided a glowing self-assessment in a recent report. The CDRH [...]
Prioritize QMS Process Automation or Risk Failure
A common pitfall in QMS process automation occurs with a poorly planned process automation strategy. Too often, the tem [...]
