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Industry-leading regulatory and quality engineering services throughout the entire product lifecycle.

 

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Regulatory

R&Q has worked in every FDA medical device clinical specialty. We provide leadership and expertise for regulatory strategy domestically and internationally... and the execution to make it all happen.

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Quality Systems

R&Q implements the right systems for your needs. We use a customized and business-balanced approach to developing and/or streamlining quality systems. No cookie cutter solutions here. The result is what you need.

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Design Assurance

We ensure a better product goes to market. We specialize in verification and validation, human factors/usability, safety risk management, and design quality. With our help, create your very best device.

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Product Quality

See your device come to life. Our services include supplier quality and audits, manufacturing site transfer, manufacturing quality, and process validation. The time is now to get it right, and R&Q helps you do just that.

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Post-Market Surveillance

Ensure your device is safe and effective. R&Q provides the leadership and expertise - and the tactical resources - to systematically monitor and evaluate performance… and execute corrective actions when necessary.

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Remediation

Been there, done that… many times. Unlike competitors, R&Q provides best practice strategic and tactical solutions to address 483 findings, warning letters, and consent decrees. We work with the FDA, not against them.


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