Pilot studies are the cornerstone of successful medical device development, serving as a critical step in validating safety, efficacy, and feasibility. At RQM+, we specialize in medical device clinical trial design, delivering tailored pilot studies that align with your product’s unique needs.  

Partner with us to mitigate risk, refine your pilot study design, and seamlessly transition to pivotal studies — all while securing quality data and patient safety. 

Partnering with RQM+ means: 

  • Tailored Trial Design

    Customized early feasibility studies that are aligned with your product goals.

  • Regulatory Precision

    Address compliance requirements early to ensure a smooth transition to pivotal trials.

  • Informed Insights

    Generate critical data to refine product development and trial strategies.

  • Risk Mitigation

    Identify potential challenges before they escalate.

Core Services for Medical Device Pilot Studies

Early feasibility studies customized to your product’s lifecycle stage and target markets 

Aligning trials with U.S., EU, and global compliance standards  

Efficient management of site strategy, activation, and operational execution 

Collection and analysis of meaningful data to inform pivotal trials

We know MedTech pilot studies because we: 

  • Supported our partners’ pilot studies across diverse therapeutic areas, including cardiovascular, neurology, and oncology 
  • Helped leading MedTech innovators successfully transition pilot studies into pivotal trials with regulatory precision 

Your pilot trial should be the firm foundation for your MedTech success. With RQM+ as your trusted partner, you gain the expertise, guidance, and quality data needed to satisfy regulators and validate your product. 

Make Your MedTech Happen

Ready to design your next clinical trial? Let’s make your pilot study happen.

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