In the medtech space, all roads lead to quality. Unlike pharma, which looks at safety and quality separately, all of the information around risk and vigilance to inform product improvement will be housed within a medtech company’s quality management system (QMS).

The primary goal of post-market surveillance (PMS) systems is to see improvements over time in terms of reduced adverse events in post-market environments. However, we are currently not seeing the continuous improvement in products that we should in medical devices on the market.

To combat this, the U.S. Food and Drug Administration (FDA), European Union (EU), and others are at work setting up sophisticated new monitoring requirements.

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