EU MDR / IVDR
CER / PER and
Expert Implementers
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Make regulatory work for you. R&Q has
worked in every clinical
leadership and expertise to get to market.
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No cookie cutter solutions here. R&Q uses a customized, business-balanced approach to developing and streamlining quality systems.
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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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R&Q tactical resources systematically monitor and evaluate performance, and execute
corrective actions when necessary.
Strategic and tactical solutions for notified body non-conformity reports, along with FDA consent decrees, 483 findings, and warning letters.
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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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ISO 9001
certified -
Integrated
team 
Strategic
and tactical-
Cost-balanced
and scalable 
Engineered
by women
R&Q is
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
– 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
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
