Medtech Magazine:

In a recent Medtech Magazine article, Anna-Karin Alm asserts that post-market surveillance (PMS) is often a neglected but crucial component of medtech regulation. Alm argues that PMS should be viewed not as a regulatory burden, but as a strategic investment. A robust PMS system, she emphasizes, is essential for safeguarding patients, significantly enhancing product quality, and fostering long-term user trust. By systematically analyzing product performance data, manufacturers can proactively identify potential risks and areas for product improvement. Moreover, Alm highlights the tangible business benefits of a well-functioning PMS system, including a stronger position during regulatory inspections and potentially expedited market entry for new products. She concludes that many companies are currently failing to realize these advantages due to fragmented and reactive approaches to data collection.