Are You Ready for US Medical Device Reporting Code Transition?
This white paper outlines the current coding requirements for reporting adverse medical device events to the US Federal Food and Drug Administration (FDA) and the International Medical Device Regulators Forum.
Each year, several hundred thousand medical device reports of suspected device-associated deaths, serious injuries and malfunctions are reported to the FDA. As one of its post-market surveillance tools, the FDA uses medical device reporting (MDR) to monitor device performance, detect potential device-related safety issues and contribute to benefit risk-assessment of these products.
Download this free white paper to find out more.