R&Q and Maetrics have merged to become RQM+, the largest medical device and diagnostics focused full-service regulatory and quality consulting firm in the world. The integration of our leadership teams and extensive skills and experience of our collective resources have created a highly agile, scalable, and global organization.

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The regulatory and quality landscape for medical devices and diagnostics is constantly evolving. When your team is overwhelmed, you can trust our committed experts to deliver high-value solutions that exceed expectations.

Unrivaled collective knowledge
Unrivaled collective knowledge

Our global team of clinical and regulatory experts has experience across all types of clinical specialties, notified bodies, classifications, risk levels, geographies, and companies. We don’t rest on this expertise—our team is constantly learning and sharing knowledge so we have the answers before you even know what questions to ask.

Long-term strategic partnerships
Long-term strategic partnerships

RQM+ is changing the way medical device and diagnostics manufacturers use consulting. Think of us as an extension of your business and a trusted partner that is invested in your strategic plan and always looking out for you.

Business-balanced solutions
Business-balanced solutions

We do more than just regulatory submissions. Our seasoned team works with yours to evaluate risk, prioritize the most impactful products, and implement a right-sized plan that makes sense for your business.

“I am amazed at how much work and the number of decisions that have been made to date on this project! I really appreciate the effort and patience of your entire team! Lots of work to go in 2021, but I am grateful that your team is helping us manage through this process.”
Director, Regulatory Affairs

"IVDR Implementation Project"
Global Medical Device and Diagnostics Manufacturer

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Our unrivaled collective knowledge and risk-balanced approach bring transformative solutions to every project we undertake. Leading industry experts offer wisdom, honesty, and friendly collaboration at every turn, making for a rewarding partnership centered on your success.

Regulatory Affairs

RQM+ 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 and IVDR to make positive business impacts and set your organization up for greater success.

Quality Management Systems

RQM+ uses a customized and business-balanced approach along with best and proven practices to developing and remediating quality systems. And our dedicated global audit team has you covered, from internal and supplier audits to mock FDA inspections.

Design Quality Engineering
& Manufacturing QA

Our design assurance, risk management, and manufacturing quality experts help you create and manufacture your very best device and stay competitive, while ensuring compliance to the latest regulations.

Regulatory Compliance

RQM+ provides the all-encompassing solution including strategic leadership, program management, and a tactical team to address all challenges. These include FDA 483's, warning letters and consent decrees, along with notified body non-conformity reports. No challenge is too big.

Post-Market Surveillance

Requirements for PMS deliverables have grown dramatically thanks to the MDR and IVDR. RQM+ has extensive thought leadership and expertise creating PMS and PMCF/PMPF plans and PSURS, along with development and execution of user surveys. Successful integration of PMS, CERs/PERs, and Risk Management is a key to success.

Clinical Regulatory Affairs

RQM+ CERs and PERs are like no others. Our team of subject matter experts has the unique combination of clinical and regulatory expertise. Led by Amie Smirthwaite, recent Global Head of Clinical Compliance at BSI, we provide an accurate assessment of sufficient clinical/performance data and effective strategies for filling the gaps to enable CE marking.


R&Q and Maetrics are Stronger Together

RQM+ was born from a mutual desire to provide high-value transformative solutions for our clients with regulatory and quality needs. Our resources are our biggest asset and we invest heavily in ongoing learning and development. Our seasoned leadership combined with the collective knowledge and passion of our team members sets us apart from other consulting firms. Want proof? We're proud to share references and testimonials.

Explore the R&Q Website Explore the Maetrics Website
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Get Started with RQM+

We are passionate about your success. Tell us more about your regulatory and quality needs to learn more about how we can help.