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Clear, actionable intelligence for regulated industries.
Expert perspectives that simplify complexity and support stronger quality and compliance outcomes.
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 [...]
