Managing Change Control in ISO 13485
Change control is a vital aspect of quality management for medical device companies. ISO 13485, the international standard for medical device quality management systems, places emphasis on change management. The process of change control in ISO 13485 ensures that modifications to products, processes, or documentation are implemented in a controlled manner. This helps maintain product […]
Feedback Instead of Complaints? The Key Differences
Have you ever wondered if it might be possible to simply move a complaint into a less burdensome category like feedback? This thought can easily arise when quality goals are narrowly missed and the pressure to deliver good metrics grows. That’s exactly what I came across recently: the question of whether complaints could be declared […]
