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Electronic Medical Device Reporting Best Practices

Steps for a smooth transition from paper-based reporting

Joby George
Tue, 11/03/2009 - 07:32
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The FDA’s Center for Devices and Radiological Health (CDRH) posted a notice of draft guidance that will require all medical device adverse-event reports to be submitted electronically. While the process of electronic submission of data is a more efficient and traceable means for reporting, it could prove to be a very long and challenging road for the average medical device manufacturer to transition from its current paper-based reporting process to an electronic reporting process.

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To ensure success, this transition needs to be very carefully planned out and executed to guarantee continued compliance and ongoing integrity with regard to the company’s product adverse-event reporting and customer satisfaction.

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