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Inefficient medical device reporting presents a clear and present danger: It can damage your company’s reputation and even threaten your ability to operate. After sending some mixed signals in the second half of 2007, FDA eMDR experts have said that they’ll mandate eMDR within two years. The only debate now is how quickly it will happen, and what kind of extension smaller device companies may get.

The way it works today: Device companies use overnight couriers or fax one of several forms within 30 days of becoming aware of an adverse event. The FDA processes them by hand in a large warehouse-type room much like a giant mail sorting facility. These forms must then be re-entered into the system by FDA data entry contractors. This takes time and data entry errors are more likely to occur.

It’s therefore not surprising to learn that the agency is pushing harder for eMDR (electronic medical device reporting) than anyone else. Sign up today to learn more about the future of eMDR, the options available to you now, and why it makes good business sense to implement an electronic medical device reporting system today.