A Data-Driven Approach to Quality Risk Management

The international medical device industry has enjoyed tremendous growth. This growth has driven innovation for complex medical devices that have broadened the treatments available to patients with complex diagnoses and other conditions.

To systematically reduce harm to patients and users, proactively detect signals and trends, and continuously improve quality and safety of medical devices through real-world evidence, quality risk management must successfully integrate risk communication throughout the quality management system.

Alongside this integration comes the benefits of fast quality decision-making with proactive solutions for medical device professionals. This paper provides insights into the methods and benefits of digitally integrating a quality risk management program to the quality management system.