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With 40 years of regulatory expertise, RQM+ has the largest global team of MedTech regulatory and quality consultants. We reduce commercialization risk by offering a full complement of CRO services to get medical devices, digital therapeutics and diagnostics on the market and keep them there. Watch the video below to learn about our multiple business units and differentiated, end-to-end services.
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!
What RQM+ Can Do for You
Whether you need occasional support with product strategies or a dedicated team that handles all of your commercialization needs, our team is here for you.
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.
RQM+ delivers transformative solutions. The results speak for themselves.
RQM+ provides comprehensive, high-quality commercialization solutions to help MedTech manufacturers get their products on the market and keep them there. Our experts are our greatest asset and we heavily invest in ongoing learning and development.
Regulatory Insights
In The Trenches
Industry Leaders
Committee Participation
RQM+ is the leading, global MedTech CRO offering consulting, clinical trial, lab and reimbursement services to support the entire product lifecycle.
RA/QA Consulting Services
RQM+ has worked in every clinical specialty and has the leadership and expertise to get your safe and effective product to market and keep it there. 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 Quality Management Systems
Lab Services
Through innovative new processes, we provide chemical characterization and complex product deformulation as well as contaminant and failure investigations to MedTech manufacturers. Our team of Ph.D. analytical chemists uses a proprietary, multi-detector approach to ensure that all extractables are accurately characterized to comply with global materials testing regulatory requirements. Additionally, our publications are frequently cited by both regulators and industry.
Clinical Trial Services
We use innovative digital tools to ensure industry-leading transparency, speed and agility, which enables MedTech manufacturers to make better data-driven decisions for patients. Our comprehensive suite of CRO services supports clinical trials throughout North America and Europe.
Reimbursement Services
MedTech companies need a team of experts to achieve the right reimbursement strategy — one focused on proper coding, appropriate insurance coverage and adequate payment. Our veteran team includes former health plan executives, physicians, health economists and certified professional coders from the medical technology, biotechnology, pharmaceutical and healthcare industries.
We are passionate about your success. Tell us more about your needs so we can help.
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