Risk Management in ISO 13485
In December 2023, the U.S. Food and Drug Administration (FDA) expects to issue [...]
In December 2023, the U.S. Food and Drug Administration (FDA) expects to issue [...]
Mistakes around standard operating procedure (SOP) management are widespread and [...]
Design controls are a frequent citation in 483 observations and warning letters [...]
Effective complaint handling is fundamental to life sciences quality management, [...]
AssurX will be exhibiting at this year’s ASQ World Conference on Quality & [...]
European Union (EU) Medical Device Regulation (MDR) and In-Vitro Device Regulati [...]
Companies marketing devices in the European Union are facing a perfect storm of [...]
From food and beverage to electronics to CPG, there’s not a single type of manuf [...]
From Listeria in ice cream to E. coli in lettuce, there’s one central question i [...]
Software validation is historically one of the most difficult compliance activit [...]