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 [...]
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 [...]
In 2021, the U.S. Occupational Safety and Health Administration (OSHA) conducted [...]
Recent ISO data shows a growing number of certificates being issued across all s [...]
In September 2022, the (FDA) released draft computer systems assurance (CSA) gui [...]
In FDA and ISO environments, quality audits are a process of examination and sub [...]
Root cause analysis is a common weak spot in manufacturing, causing numerous qua [...]