REU Associates

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Office: 440.840.0949
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Medical Device Remediation Services

The last thing any medical device manufacturer wants to receive is an FDA form 483 or FDA warning letter. Are you prepared to handle the implications of Form 483 and/or a warning letter? REU Associates can assist with the development and implementation of a warning letter remediation plan to bring your company into full compliance. Our remediation solutions will help your organization:


Analyze the results of the FDA 483 and/or FDA warning letter.

Formulate an effective response to an FDA 483 and/or warning letter.

Arrange a timeline to meet agency expectations.

Develop a remediation plan to identify all causes for deficiencies.

Answer any of your questions or questions from the FDA.

Implement improvements to ensure total compliance.


REU Associates will help you navigate the FDA regulatory process and make sure your company meets all requirements for product clearance and approval. With vast experience in the medical device industry, REU Associates has the leadership, expertise and tools necessary to generate complete FDA compliance so you can return to business as usual.


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