Industry Regulation White Paper
Currently, medical device manufacturers are required by the Federal Food, Drug & Cosmetics (FFD&C) Act to submit Medical Device Reports when their devices are involved in patient safety issues or product malfunctions. The FDA urges device manufacturers to voluntarily adopt the agency’s electronic Medical Device Reporting (eMDR) process before it becomes mandatory.
This white paper will address the key industry challenges facing medical device manufacturers, including the regulatory criticality of properly handling customer complaints, and the subsequent submission of adverse event reports. It will guide you in your understanding of the eMDR process and what your enterprise needs to do to make the move to electronic submissions.
Download this white paper to learn more. »