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Manufacturer and User Facility Device Experience Database - (MAUDE)

File Formats for FOI Releasable Data

The FDA announced that they have updated their files for the MDR reporting. This file is a very useful file for reviewing competitor’s devices and determine potential problems especially when working on new device designs or changing your present device design.

The more you can learn of potential problems with similar devices the better it would be for your device design to try to avoid these problems with your design.

Reviewing these files should be an integral part of your FMEA and Fault Tree analysis.

You can find this file at the following website:

http://www.fda.gov/cdrh/maude.html

For any questions concerning MDR and the Maude reports please contact mdi at info@mdiconsultants.com

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