RQM+ is The MedTech CRO

RQM+ is The MedTech CRO — a full-service partner supporting everything from groundbreaking innovation to well-established technologies. Our coordinated and comprehensive solutions are customized to each client’s product and life cycle stage. By aligning strategy and execution in one partner, we help reduce cost, accelerate timelines, and drive more successful outcomes.

The Integrated Advantage

RQM+ unifies four core service areas to streamline your product life cycle:

Regulatory & Quality

Expert regulatory strategy, global submissions, quality system design, audits, and compliance guidance—grounded in decades of FDA and EU MDR/IVDR experience. Reduce risk and assure global compliance from the start.

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Clinical Trials

Comprehensive clinical management—from early feasibility through post-market studies. Data-driven trial execution ensures operational efficiency, patient safety, and timely market approval.

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Reimbursement

Proven strategies in coding, coverage, and market access, expertly aligning your regulatory and clinical data with payer requirements. We turn your innovation into patient access and revenue sooner.

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Lab & Material Science

Jordi Labs sets the gold standard in extractables & leachables, biocompatibility testing, chemical characterization, and failure analysis. Trusted by the FDA and global regulators, our lab results enable confident submissions and safer products.

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Being “The” MedTech CRO Means…

Simplified Vendor Management

Integrated services spanning regulatory, clinical, laboratory, and reimbursement, reducing vendor handoffs and eliminating knowledge gaps.
Flexible Scaling Without Risk

Adaptable partnering models—outsourcing, consulting, and embedded staffing—provide the exact support your business demands.
Setbacks? No Thanks.

Industry-leading risk management combined with FDA-recognized laboratory services from Jordi Labs ensures precision and reliability at every turn.
Fast, Accurate, Reliable

1,300+ clinical studies and 5,000+ consulting projects refined our processes to achieve faster, compliant market access.

Flexible Partnering Solutions

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Outsourcing

Customizable and scalable outsourcing scoped for entire projects, specific functions, or defined parts of a function. Leverage RQM+ expertise and flexibility while your teams stay focused on core competencies, corporate goals, and innovation. Partner with us.

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Consulting

Targeted, outcome-focused expertise to solve defined MedTech challenges. RQM+
consultants step in with practical, actionable guidance and hands-on execution to drive timely resolution. Partner with us.

Staff Augmentation

Fill skill or capacity gaps with MedTech talent from RQM+. We provide on-demand professionals, functional service support, fast deployment for tight timelines, and contract-to-hire options that integrate seamlessly with your team. Match with a contractor.

Access Device-Specific Expertise

Whatever your MedTech area of need, we’ve got you covered. Discover our expertise for your product type:

Medical Devices

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In Vitro Diagnostics

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Combination Products

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Software-Enabled Products

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“The professionalism, attentiveness, and unwavering partnership shown by the team truly impressed us. Their dedication in overcoming challenges and delays significantly advanced our project.”

Director of R&D, Contract Testing Laboratory

“Great team, great knowledge and insights in helping small, young startups navigate gaining clearance from FDA on new devices.”

COO, Global Medical Device Manufacturer

What It Means to Be The MedTech CRO

Simplify your product life cycle, accelerate timelines, and reduce costs with RQM+.

The Integrated Advantage

Being “The” MedTech CRO Means…

Simplified Vendor Management

Flexible Scaling Without Risk

Setbacks? No Thanks.

Fast, Accurate, Reliable

Flexible Partnering Solutions

Outsourcing

Consulting

Staff Augmentation

Access Device-Specific Expertise

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