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Regulatory Focus™ > News Articles > Compliance Advice: Establishing a Compliance Program

Compliance Advice: Establishing a Compliance Program

Posted 01 January 2008

Thank you for helping me with my previous questions about product complaints that I suspected were reportable to FDA under the Medical Device Reporting regulations. Now I have discovered a few problems with our complaint investigation and reporting procedures and wonder if you have any advice for preventing or detecting these and other compliance issues in the future.

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