RQM+

Executive Summary

RQM+ is a specialized Contract Research Organization (CRO) providing end-to-end support exclusively for the medical technology (MedTech) sector. Founded in 2018 and headquartered in San Diego, the company offers comprehensive services spanning regulatory strategy, quality systems, clinical trials, laboratory testing, and reimbursement. Its focus on medical devices, in vitro diagnostics (IVD), software as a medical device (SaMD), and combination products positions it as a key partner for MedTech innovators navigating complex global regulatory landscapes. With the increasing adoption of AI and machine learning in diagnostics and digital health, RQM+ is well-positioned to capitalize on the growing need for specialized regulatory and clinical expertise in these emerging areas. The MedTech CRO market is experiencing robust growth driven by factors such as the implementation of the EU Medical Device Regulation (EU MDR) and the FDA's evolving oversight of software-based devices. As a private company, RQM+ may leverage these trends to expand its client base and service offerings. Upcoming catalysts include heightened demand for EU MDR compliance support, potential FDA guidance on AI/ML-enabled medical devices, and the company's possible expansion into international markets. These factors could drive revenue growth and potentially lead to strategic partnerships or investment opportunities.

Upcoming Catalysts (preview)

• Q3 2026EU MDR Implementation Driving Demand for Regulatory Consulting85% success
• Q4 2026FDA Final Guidance on AI/ML in Medical Devices60% success
• H1 2027Expansion into Asia-Pacific MedTech Markets50% success