R&Q provides best practice strategic and tactical solutions to address any and all challenges. These include notified body non-conformity reports, along with FDA consent decrees, 483 findings, and warning letters.

Remediation services

Scalable team: strategic, tactical, and creative
DHF and technical documentation remediation
Complaint files and device reporting
483, warning letter, consent decree responses and execution
Notified body non-conformity report corrective action plans and execution

Contact us for assistance.

"We have many firms working on this remediation and R&Q is by far the best we have used to date. From their program management to their technical skill they far outpace the others."

- VP of Regulatory and Quality, Remediation Support, Large Medical Device Company

 

"The R&Q team members are knowledgeable and take the time to tailor their services to 'fit your real needs.' If you are in need of regulatory and quality support in the med-tech industry I recommend reaching out to R&Q."

- VP of Quality and Regulatory Affairs, Remediation Support, Large Multinational Medical Device Company

Contact us

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