Get your medical devices to market and keep them there.

Industry-leading regulatory and quality consulting and engineering for medical devices, IVDs, and combination products.

In the midst of the COVID-19 pandemic, please know R&Q's ISO 9001 certified quality system has processes designed to enable the performance of any service remotely. Supporting clients in this way is business as usual for us. See how we do it.

How we help

Industry-leading regulatory and quality consulting and engineering services. That's how.

Our services help you get safe and effective medical devices to market... and keep them there.

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Make regulatory work for you. R&Q has
worked in every clinical specialty and has the
leadership and expertise to get to market.

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Quality Systems

No cookie cutter solutions here. R&Q uses a customized, business-balanced approach to developing and streamlining quality systems.

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Quality Assurance

Why settle for less? R&Q ensures your most exceptional product goes to market. With our help, create your best device.

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Post-Market Surveillance

R&Q tactical resources systematically monitor and evaluate performance, and execute
corrective actions when necessary.

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Strategic and tactical solutions for notified body non-conformity reports, along with FDA consent decrees, 483 findings, and warning letters.

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Project Management

Across all R&Q services: Best-in-class, PMP-certified project managers who are seasoned device professionals focused on RA/QA.

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What sets R&Q apart

R&Q is lSO 9001:2015 Quality Management certified by BSI under certificate number FS565132.

We're focused on consistently exceeding customer and shareholder expectations by delivering the highest quality service on every engagement. We:

– Understand customer goals and embrace them
– Focus efforts on timely, accurate, and effective service
– Ensure compliance to applicable regulations
– Continually improve the effectiveness of our services and QMS
– Hire high performing team members motivated by client success
– Provide ongoing growth and development opportunities to empower our greatest asset: our team

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When you hire R&Q you benefit from our collective experience, which is significantly more than what an individual consultant can offer.

– We don't throw bodies at projects (not a staffing firm)
– Best practices and case studies available when you need them
– Resources adaptable to your situation and ready to go when you are


R&Q is unique because our 30-year veterans plan the strategy and execute.

– Every employee professionally trained and experienced
– High-performing staff at all levels, including technical experts, proven project managers, and 30-year veterans who actually do the work
– Skill levels optimal for your project are skill levels you receive
– All projects customized to client needs
– Best-in-business project management


R&Q blends high-level and low-level resources (and everything in between) to provide the perfect mixed teams for your projects and cost-efficient completion.

– Multiple models, including retainers, project-based, fixed-fee, T&M (time & materials), and tiger teams
– Only billed for what we do... nothing more
– Those full-time resources you get from another company? A part-time R&Q employee may accomplish just as much – if not more – in the same time frame (ask us for testimonials)


R&Q's strategic executive team consists of seven medical device industry movers and shakers... six of whom are women.

– Led by cofounders and owners Maria Fagan and Lisa Casavant
– In addition to the importance of gender and fairness issues, women entrepreneurship fuels economic growth

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Every team member plays a part in improving lives.

The team at R&Q is made up of industry-leading experts who care deeply about helping medical device and combination product companies achieve success and improve lives.

Would you like to be part of that?

Get to know us and meet the team!

Contact us

Complete the form below and we'll respond within 48 hours.

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