About
RQM+ is the leading MedTech CRO, providing end-to-end support for medical device, diagnostic, and combination product manufacturers. Our tailored solutions throughout the product life cycle deliver regulatory and quality expertise, FDA-recognized laboratory services, clinical trials, and reimbursement strategies across device types and therapeutic areas to bring life-changing technologies to patients — faster, safer, better.
Products & Services
- SMART Solutions: SMART Solutions is RQM+’s strategic life cycle partnership model designed to replace fragmented, siloed workstreams with a unified operating framework. By integrating regulatory, quality, clinical, reimbursement, and laboratory expertise into a single cohesive team, the model identifies potential roadblocks early to significantly reduce risk. It offers scalability through two distinct engagement paths: Integrated SMART Solutions, providing full-service lifecycle support for small-to-midsize enterprises, and Functional SMART Solutions, which delivers targeted excellence for larger organizations.
- Clinical Trials: We bridge the gap between clinical innovation and patient impact by providing comprehensive, end-to-end trial services tailored specifically to the medical device industry. By leveraging deep therapeutic expertise across all study phases—from early feasibility to post-market surveillance—they prioritize compliance, safety, and operational efficiency to ensure reliable data and meaningful outcomes.
- Lab & Material Science (via Jordi Labs): With 40+ years of experience, we specialize in comprehensive analytical lab and material science tailored to meet the needs of medical devices, pharmaceuticals, consumer products, and polymers. Jordi Labs, an RQM+ company, is recognized by the FDA as the gold standard in chemical characterization and extractables and leachables (E&L) testing, providing critical insights that ensure product safety and regulatory compliance on time.
- Regulatory & Quality (RA/QA): Backed by 50+ years of direct FDA experience, we offer MedTech regulatory affairs and quality assurance solutions that help innovators achieve and maintain global compliance. From product development to post-market support, our integrated approach equips you to stay ahead of evolving standards while keeping your product pipeline on track.
- Reimbursement: Securing reimbursement is a critical yet complex necessity for bringing medical innovations to market. Our team of seasoned experts leverages decades of regulatory and clinical experience to provide proven strategies that overcome market access hurdles and secure coverage. By streamlining the path from development to patient, we help increase revenue and ensure your product achieves long-term commercial success.