AssurX Blog
Straight talk for regulated industries.
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 System Regulation (QSR). The biggest change is that the new Qual [...]
SOP in QMS
Mistakes around standard operating procedure (SOP) management are widespread and costly, especially given the pace of change in manufacturing today. Consider, for example, an electron [...]
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 Administration (FDA). In fact, the agency has noted a large proportion of pa [...]
Complaint Management for Life Sciences with an Automated QMS
Effective complaint handling is fundamental to life sciences quality management, with implications for operations, product design, risk management, and more. It’s also critical to ISO [...]
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 be held at the Pennsylvania Convention Center (1101 Arch Street, [...]
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 safety. However, ongoing challenges have resulted in a new extension [...]
