Strategies And Standards For Medical Device Signal Detection

By Christine Berard, Global Head of Quality and Regulatory, KMC Systems

The Center for Devices and Radiological Health (CDRH), a branch of the U.S. Food and Drug Administration, announced four long term strategies to strengthen its National System for Medical Device Post-Market Surveillance that can actually correlate with medical device signal detection. These strategies are designed to improve the collection, analysis, synthesis, and action of medical device benefit-risk assessments. Based on these, the medical device industry is taking a more progressive approach with medical device signal detection. Download this article for more information on these strategies and standards that are used for medical device signal detection.