R&Q and Maetrics have merged to become RQM+. The integration of our leadership teams and extensive skills and experience of our collective resources have created a highly agile, scalable, and global organization.

RG Maetrics

Unrivaled Collective Knowledge

One of our greatest strengths is the unrivaled collective knowledge our team brings to your projects. There are several factors to consider when choosing a regulatory and quality partner, and one of the most important is evolving expertise.

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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.


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 as a trusted partner that is invested in your strategic plan and always looking out for you.


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 plan that makes sense for your business.


Collaborative, Integrated Teams

We’re a trusted partner that seamlessly integrates with your team to deliver best-in-class regulatory and quality solutions. We’re genuinely here to support our clients with wisdom, expertise, and tailor-made solutions.


Laser Focus on Client Success

We only recruit service-minded people who truly want to help their clients and, ultimately, the patients served. This allows us to deliver solutions that support business success and help clients stay competitive in the marketplace.

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NAVIGATE AND FILTER
THE IVDR AND MDR

Our new series of interactive tools allow you to easily filter lines of the IVDR and MDR by topic, chapter, section, article, and any search term. Many of our experts have this tool open at all times on their computers for quick access and it's been a game changer. Now we're sharing them with you!

 

Explore IVDR ToolExplore MDR Tool

What RQM+ Can Do for You

Whether you need occasional support with product strategies or a dedicated team that handles all of your regulatory and quality needs, our team is here for you.

Path

Our experts are collaborative, laser-focused on client needs, and committed to delivering high-value solutions that exceed expectations. With former FDA and EU regulators on staff, our team is ready to work with yours to evaluate risk, prioritize the most impactful products, and implement a plan that makes sense for your business.

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RQM+ delivers transformative solutions. The results speak for themselves.

1,000+ Clients
5,000+ Completed Projects
9.6 Average Net Promoter Score
90% Repeat Business Rate

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RQM+ was born from a desire to provide high-value transformative solutions for our clients with regulatory and quality needs. Our resources are our biggest asset and we heavily invest in ongoing learning and development.

“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


RQM+ provides worldwide and industry-leading regulatory and quality consulting and engineering for medical devices and IVDs.

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Regulatory Affairs

RQM+ has worked in every clinical specialty and has the leadership and expertise to get your safe and effective product 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.

Explore Medical Device Regulatory Affairs

Explore In Vitro Diagnostics Regulatory Affairs

Explore Combination Products

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Quality Management Systems

RQM+ uses a customized, business-balanced approach alongside proven best practices to develop and optimize quality systems. Our dedicated global audit team has you covered, from internal and supplier audits to mock FDA inspections.

Explore Quality Management Systems

Explore Audits and Inspections

Explore Quality System Regulations and Standards

Explore Acquisition Integration

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Design Quality Engineering & Manufacturing QA

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

Explore Design Quality Engineering and Manufacturing QA

Explore Design Quality 

Explore Manufacturing Quality

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Regulatory Compliance

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

Explore Regulatory Compliance

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Post-Market Surveillance

Requirements for PMS deliverables have drastically grown thanks to the MDR and IVDR. RQM+ has extensive thought leadership and expertise in creating PMS, PSURs, and PMCF/PMPF plans, along with developing and executing user surveys. Successful integration of PMS, CERs and PERs, and risk management is a key to success.

Explore Post-Market Surveillance for Medical Devices 

Explore Post-Market Surveillance for In Vitro Diagnostics

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Clinical Regulatory Affairs

RQM+ CERs and PERs are like no others. Led by Dr. Amie Smirthwaite, recent global head of clinical compliance at BSI, our team provides comprehensive clinical regulatory strategies including an accurate assessment of sufficient clinical performance data and effective strategies for filling in the gaps to enable CE marking.

Explore Clinical Evaluation Plans/Reports (CERs)

Explore Performance Evaluation Plans/Reports (PERs)

 

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

Book a Consultation

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