The Importance of a Medical Device Surveillance Registry Process

Performing a risk assessment of medical devices is extremely important. This is a critical process for ensuring safety, effectiveness, and ongoing improvement of products in the market. It requires careful planning, adherence to regulatory requirements, and a robust data management system to collect, analyze, and report data effectively. This work presents an overview and a methodological proposal on how a medical device surveillance registry process can be done, collecting data from several sources, emphasizing the process requirements and the fulfillment of regulatory obligations, and presents a demonstrative example for the proposed methodology.