Supply Chain Complexity Hampers Medical Device Company Operations, Compliance

MBT -- Despite the FDA’s recently announced timetable, nearly 60 percent of medical device industry professionals report that they have not begun preparing for the electronic medical device reporting mandate (eMDR), which requires automated submission of post-market adverse events. Without adequate preparation for this mandate, companies not only remain exposed for potential fines and citations, but also for greater device safety issues if they don’t report and resolve these issues quickly.

MORE ON THIS TOPIC