Having trouble understanding and interpreting all the new post-market surveillance requirements? R&Q has answers and is available to help you keep your devices safe and effective... and your business grow. Our dedicated (and highly qualified/proficient) team stays on top of the newest regulations, industry trends, and uses our industry connections to grasp what our competition might not.

Post-market surveillance services

EU MDR PMS: Plan, PMCF, PMSR, PSUR, SS&CP
Form 483, warning letter, and consent decree strategy and remediation support
CAPA leadership and execution
Complaint handling and MDR submissions
Recall strategy and execution
PMS/CER/Risk integration

Contact us for assistance.

Understand the risk.

Analyze and evaluate what could happen to your medical device. The concept of preparing for the worst is not fun to consider, but it's imperative for longstanding success. R&Q has seasoned experts in all aspects of post-market surveillance and can help you put a plan in place: carefully, yet quickly and efficiently.

Keep the momentum.

CAPA, complaint, and safety risk monitoring are three critical components that ultimately allow your medical device company to succeed. And if you face an unfortunate recall, R&Q has successfully handled many of them and can help you. We will diligently work with your team to ensure all details of the recall are squared away.

Contact us

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