We Don’t Make MedTech

We Make MedTech Happen

Adding expertise from concept to post-market

We don’t build medical devices.

We make them market-ready.

We don’t invent life-changing diagnostics.

We make sure they meet global standards.

We don’t create combination products.

We make them accessible to patients.

We accelerate your advancement with expert services across numerous therapeutic areas and device types, uncovering and resolving hurdles throughout your product’s life cycle. Whether it’s regulatory strategy, clinical trials, lab & material science, or reimbursement support, we collaborate with you to deliver MedTech solutions that bring your product to patients — faster, safer, better.

Circular infographic depicting the seven stages of a medical-device lifecycle arranged clockwise around a central plus symbol with four pink dots. Starting at the top and moving right: Concept & Feasibility – dark blue circle with a white lightbulb icon Design & Development – dark blue circle with a white laptop and gear icon Verification & Validation – dark blue circle with a white document and checkmark icon Manufacturing Readiness – dark blue circle with a white factory and magnifying-glass icon Regulatory Submissions – dark blue circle with a white clipboard and checkmark icon Market Launch – dark blue circle with a white medicine bottle and pill icon Post-Market Surveillance & Ongoing Compliance – dark blue circle with a white hand holding a medical cross icon The circles are linked by a continuous gradient arrow that fades from yellow through orange and red to pink.

Why RQM+

Guiding your MedTech journey with faster solutions, fewer obstacles, and complete support from start to finish:

  • Faster Time to Market

    Reduce regulatory delays with precise, experienced guidance.

  • Lower Risk

    Identify and resolve challenges before they escalate.

  • Comprehensive Support

    From concept to post-market, we ensure every step is seamless.

Flexible Partnering Solutions

Full-Service Outsourcing

Full-Service Outsourcing

End-to-end project ownership, from strategy to execution. Our managed outsourcing solutions enable easy collaboration, streamlined operations, and expert oversight so you can focus on what you do best.

Professional Consulting

Professional Consulting

Industry-leading MedTech consultants with the strategic insight and regulatory expertise to solve your toughest challenges. Our global team stays ahead of evolving regulations to keep your innovations moving forward.

Professional Staffing

Professional Staffing

Need an expert or a full team? We provide highly qualified MedTech professionals who integrate quickly and easily into your organization — the right people, right when you need them.

Delivering Real Results

Real results that demonstrate our expertise and commitment to your MedTech success:

  • 40+ Years
    of Expertise

    Delivering regulatory and quality (RA/QA) consulting excellence.

  • 19 of the Top 20 Medical
    Device Companies

    Trusted by industry leaders worldwide.

  • 7 of the Top 10 IVD
    Companies

    Chosen by innovators for their most critical projects.

  • 50% Efficiency
    Gain

    Achieved through our proprietary technology platforms.

  • Gold Standard Lab & Material Science Through Jordi Labs

    Industry-leading materials testing and chemical characterization recognized by the FDA.

  • Global
    Reach

    Successful regulatory submissions across the U.S., Europe, and the U.K.

Make Your MedTech Happen

Hear From Our Clients

Trusted by industry leaders to simplify the complex and help bring life-changing innovations to market.

“Highly recommend. I have been working with RMQ+ for the past 3 years and am very thankful for all the help and indispensable knowledge the team has brought to my organization. RQM+ talented members have helped make complex projects easy to manage and enabled our submissions to be successful. I couldn’t ask for a better company to partner with.”

Regulatory Compliance Manager, Innovative MedTech Company

“I found the people who I’ve worked with from RQM+ to be professional, knowledgeable, and friendly. It was a pleasure to work with your team! I would recommend RQM+ to a colleague without any hesitation. I would look forward to working with RQM+ on other projects in the future. Your team would be my first choice when looking for external support, should the need arise.”

Director of Quality Systems and Regulatory Affairs, Global Medical Device Manufacturer

“Very happy with ongoing support and always quick, proactive response to need for help. Very happy with expertise and guidance provided by RQM+.”

Senior Director, Innovative MedTech Company

“RQM+ provided great team work with me during the external support, the communication is good and response is fast.”

Clinical Product Manager, Global Medical Device Manufacturer

“RQM+ have been incredibly professional, knowledgeable, efficient and patient throughout our SOW. I would not hesitate to recommend your services again.”

Post Market Surveillance Manager, Innovative MedTech Company

“Our regulatory affairs manager was a great support, offered great collaboration, and I appreciated his input into this project.”

Regulatory Affairs Manager, Innovative MedTech Company

“RQM+ offered incredible support throughout the project, and the engineer recommended was extremely well-trained and provided a ton of value to the project!”

Sr. Manager Supplier Quality Engineering, Innovative MedTech Company

“I have recommended RQM+ to others and will continue to do so, and RQM+ will be the first place I turn if the need for external support arises. I depend on the support I receive from RQM+ and I trust the guidance provided to me by their expert staff.”

RA Lead, Innovative MedTech Company

“I appreciate the support provided by RQM+ and the dedication to our projects, as well as kind and efficient communication and RQM+ availability whenever there is such a need. Thank you!”

Medical Director, Innovative MedTech Company

“Absolutely a 10 for our clinical research lead. My organization is stronger thanks to her support and expertise.”

Director, Clinical Research & Scientific Affairs, Innovative MedTech Company

“Our regulatory specialist is a great support, with great collaboration and discussion. I appreciate his input into our projects.”

Regulatory Affairs Manager, Innovative MedTech Company

“Our regulatory specialist and entire RQM+ team have been very pleasant to work with and are very knowledgeable and have provided great support with our clinical documentation for EU MDR.”

Regulatory Affairs Specialist, Innovative MedTech Company

“Our design quality expert has provided excellent support. His knowledge of medical devices and regulations is very good and he takes on difficult tasks with little guidance needed.”

Sr Manager, Design Quality Assurance, Innovative MedTech Company

“As always, it is a pleasure to work with the RQM+ team. They have very knowledgeable and professional; I greatly appreciate your support!”

VP of Quality, Global Medical Device Manufacturer

“Our project lead’s team continues to provide great support for our PMS documents, they are very well organized and on track for all deliverables related to this project.”

PMS Specialist, Innovative MedTech Company

“An absolute 10. RQM+ has provided invaluable support that has made a huge impact to our team and bottom line.”

PMS Specialist, Innovative MedTech Company

Your ideas make an impact. Our expertise brings them to life.

Choose RQM+ as your partner and let’s make MedTech happen together.

Contact Us Today