Clinical trials that deliver quality data are the bridge between innovation and positive human impact. At RQM+, The MedTech CRO, we use our deep operational and therapeutic expertise to provide end-to-end clinical trial services that are tailored to the unique needs of the MedTech industry.  

With expertise across trial types — including early feasibility, pilot, pivotal, and post-market studies — and a focus on compliance, safety, and operational efficiency, we safeguard your journey to reliable results, meaningful outcomes, and informed decisions about your next steps. Want to deliver safe and effective medical devices to patients? Let’s make your MedTech happen. 

Clinical Trial Services Built for Your Success

We provide end-to-end clinical trial management solutions that are designed to deliver quality data to advance your MedTech journey. With streamlined operations, deep therapeutic expertise, and insights you can actually use, we ensure compliance, efficiency, and patient safety every step of the way. 

Tailored EFS to pilot, pivotal, and post-approval studies designed by leading experts 

Project management, site feasibility, strategy and activation, data management, medical affairs and product safety, clinical site management, CEC/DMC adjudication management and reporting, biostatistics, and medical writing 

Seamless compliance with U.S., EU, and international regulatory requirements 

We have comprehensive expertise across a wide range of therapeutic areas, with specialized focus areas for Medical Devices and IVD:

  • Cardiology 
  • Orthopedics
  • Neurology
  • Oncology
  • Ophthalmology
  • Dermatology
  • Endocrinology
  • Gastroenterology
  • Respiratory Care
  • Infectious Disease​
  • Oncology & Companion​
  • Chronic Disease & Metabolic Disorders​
  • Hematology & Immunology​
  • Neurology & Neurodegenerative Disorders​
  • Women’s & Reproductive Health​
  • Genetic & Molecular ​
  • Gastrointestinal

Why partner with RQM+ for your clinical trial consulting and management needs? Let’s count the ways: 

  • Innovative Digital Tools

    Advanced site selection and predictive data models to improve recruitment and trial success.

  • Patient-Centric Trial Models

    Real-time recruitment insights, decentralized and hybrid models, and adaptive study designs to prioritize recruitment and speed of enrollment while maintaining patient safety and outcomes.

  • Proven Regulatory Partnerships

    Strong and ongoing relationships with the FDA, MHRA, and European notified bodies to navigate complex regulations confidently.

  • Flexible Operating Models

    Customized service line packages for MedTech companies of all sizes to address specific resource and delivery needs.

  • Advanced Data Integration

    Tools for optimizing multiregional trials with seamless data sharing and analytics for sponsors as well as real-time performance.

Clinical Trial Success Stories 

  • Successfully managed trials across 20+ therapeutic areas, including oncology, cardiovascular, urology, and neurology 
  • Achieved timely approvals for 510(k) and PMA applications through optimized trial and regulatory strategies 
  • Delivered data integrity and actionable insights that shaped regulatory submissions and market access strategies 
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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.

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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

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.

Make Your MedTech Happen Clinical trials are complex, but they don’t have to be overwhelming.

You need high-quality data to advance your product safely and effectively. We deliver. Simple as that. With RQM+ as your partner, you get the expert support you need to turn challenges into opportunities. Together, we make MedTech happen — faster, safer, better.

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