Services

R&Q offers a number of industry-leading services for medical device and combination product companies.

Regulatory

Having worked in every clinical specialty, R&Q is an expert in FDA requirements for medical devices. 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 quality management 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? Exactly 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 in the long term. The R&Q team will utilize our tactical resources to systematically monitor and evaluate performance, and execute corrective actions when necessary.

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Remediation

R&Q provides best practice strategic and tactical solutions to address consent decrees, FDA 483 findings, and warning letters. We work with the FDA – not against them – to develop a comprehensive strategy to address any and all challenges.

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Contact us

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Note: If you are interested in applying for a position at R&Q, please visit the careers page.