R&Q has worked in every clinical specialty and has the leadership and expertise to get your safe and effective product(s) to market. What's more, we're using the MDR to make positive regulatory impacts and set your organization up for greater success. Sound good?

Regulatory services

Emergency Use Authorizations (EUA)
Worldwide regulatory strategy and support
FDA regulatory submissions (510(k), PMA, De Novo, etc.)
EU MDR and IVDR technical documentation
Summary of Safety and Clinical Performance (SSCP)
CERs and PERs
Regulatory compliance
Acquisition integration

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A forward-thinking strategy.

RAPS medical device regulatory affairs enterprise memberR&Q will help you accelerate the device-to-market process anywhere in the world. Your device will get to the people who need it sooner, and we all recognize what a difference that can make. Understanding the most efficient way to get your product to market matters, and making it actually happen matters more. R&Q helps medical device companies of all sizes do this. We work with you - not for you - to determine what solution is best for your needs.

Experience to lean on.

You want to put a safe and effective device on the market and ultimately improve lives - just like we do. R&Q is an industry leader who has worked in every FDA medical device clinical specialty, so you know our high-performing, adaptive team is ready for any task. Class I, Class II, Class III... we've executed on them all. Whether you face domestic or international challenges - or both - R&Q's team is prepared to become an extension of yours to get the job done.

Contact us

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