Medical device reporting: Reading between the lines

Here's what you need to know about the new clarifications on medical device reporting

By Tom Middleton, April 19, 2017.

Late last year, the U.S. Food and Drug Administration released the final guidance on Medical Device Reporting (MDR), a critical quality component of a company’s complaint management system. This guidance explains and describes the current MDR regulations found in Title 21 CFR Part 803 while clarifying sections that were previously ambiguous. The new clarifications impact all manufacturers of legally marketed medical devices in the U.S. (including foreign manufacturers who export devices to the U.S.).

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