Medtech Quality Systems Overlooked, Alarming Observation

In her column, "The Forgotten Pillar in the Medtech Regulatory Framework," Anna-Karin Alm expresses bewilderment at the common practice of medical technology companies viewing their Quality Management System (QMS) as a burden. She questions why a system intended to be a powerful support, offering clear instructions for mandatory activities, is instead perceived as mere "paperwork." Alm contends that this perspective is regrettable, advocating instead for the QMS to be treated as a valuable asset and an investment in quality and safety, rather than a burdensome obligation. The article highlights a prevalent trend where companies underestimate the supportive role their QMS can play. Alm's central observation is that, despite its critical importance, the QMS is frequently overlooked, functioning as a "forgotten pillar" within the industry.