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.

RG Maetrics

Be Your Best at RQM+

We give talented professionals a supportive and flexible environment to strategically grow their careers. 

Click here to view our open positions.


RQM+ Launches Clinical Trial Services

We are introducing new digital tools to ensure industry-leading transparency, speed and agility, which enables clients to make better data-driven decisions for patients.

Read the press release


RQM+ Acquires
Jordi Labs

Through innovative new processes, RQM+ provides 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 requirements. Our publications based on the multi-detector approach are frequently cited by both regulators and industry.

Read the press release


RQM+ Launches Reimbursement Services

We use our extensive experience with the latest reimbursement requirements and value-based compensation models, as well as key payment trends, to provide customized support that fits each company's needs.

Read the press release


Unmatched regulatory expertise

With more former FDA, Medicines and Healthcare Products Regulatory Agency (MHRA) and notified body regulators than any other firm, RQM+ has deep expertise in all clinical specialties. RQM+ currently serves eight of the top 10 medical device manufacturers and seven of the top 10 IVD companies.

spreadsheet

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 commercialization 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.

women-sitting

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

learning-development

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.

“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+ is the leading, global MedTech CRO offering consulting, clinical trial, lab and reimbursement services to support the entire product lifecycle.

part-4-icon-1-Protocols

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

Explore Post-Market Surveillance for Medical Devices

Explore Post-Market Surveillance for In Vitro Diagnostics

icon-clinical-regulatory-affairs

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.

Explore Lab Services

 

part-2-icon-4-industry-insights

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.

Explore Clinical Trial Services

icon-post-market-surveillance

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.

Explore Reimbursement Services 

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

Book a Consultation

GLOBAL BOTTOM CTA INSTRUCTIONS:

To display custom copy instead of global copy in this section, please go to Show Global Content for Bottom CTA? toggle in the "Contents" tab to the left, toggle it off, save, and then REFRESH the page editor, the custom text will then show up and ready to be edited.

Turning the global content back on will be the same process, go to the toggle and toggle it back on, save and refresh!