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Tag Archives: 510(k) NHTSA

Pacemaker, Courtesy WikiCommons, Steven Fruitsmaak

How to Post an Adverse Event with the FDA

By Mesh Medical Device Newsdesk |

MND, August 30, 2015 ~When you have a new car that develops a “safety” issue i.e. braking, steering, airbags, wiring, engine cooling, unintended acceleration etc, the auto dealer reports the problems to the manufacturer, who by law, must report the issue to the National Highway Traffic Safety Administration within five days. But when a [continue reading…]

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