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Life Sciences
Risk Management in ISO 13485
In December 2023, the U.S. Food and Drug Administration (FDA) expects to issue its long-awaited overhaul of its Quality [...]
SOP in QMS
Mistakes around standard operating procedure (SOP) management are widespread and costly, especially given the pace of c [...]
Linking Design Controls and Risk Management in the QMS
Design controls are a frequent citation in 483 observations and warning letters from the U.S. Food and Drug Administrati [...]
Complaint Management for Life Sciences with an Automated QMS
Effective complaint handling is fundamental to life sciences quality management, with implications for operations, prod [...]
AssurX Exhibiting at ASQ World Conference on Quality & Improvement (WCQI)
AssurX will be exhibiting at this year’s ASQ World Conference on Quality & Improvement (WCQI). The conference will [...]
Update: EU Medical Device Regulation Deadlines Extended
European Union (EU) Medical Device Regulation (MDR) and In-Vitro Device Regulation (IVDR) raises the bar for device safe [...]
