What RQM+ does

RQM+ is a full-service MedTech-only contract research organization (CRO) that provides integrated regulatory, quality, clinical trial, laboratory, and reimbursement services to medical device, in-vitro diagnostic (IVD), and combination product companies. The company originated as R&Q Solutions in 2008, was renamed RQM+ following the 2020 acquisition of Maetrics, and was acquired by healthcare-focused private equity firm Linden Capital Partners in 2021, after which it executed a multi-year consolidation strategy adding AcKnowledge Regulatory Strategies (2021), Jordi Labs (2022), Libra Medical (2023), and CRO Kottmann (2023). The result is a single organization spanning the full product life cycle — from concept through regulatory submission, clinical evidence generation, laboratory testing, and market access — with offices in the US (Cary, NC; Mansfield, MA), the UK (Altrincham), Switzerland (Basel), and Germany (Frankfurt, Ahlen). The company reports a roster of 19 of the Top 20 medical device companies and 7 of the Top 10 IVD companies, with 1,300+ clinical studies and 5,000+ consulting projects completed across more than 1,000 clients.

RQM+ monetizes through three core engagement models — multi-year full-service outsourcing, targeted professional consulting, and on-demand professional staffing (with a self-serve contractor matching platform) — plus standalone laboratory services delivered through the Jordi Labs subsidiary. Pricing is quote-based and not publicly disclosed. The technology stack includes the SMART Solutions life cycle partnership framework (launched March 2026), which provides KPI-driven integrated governance over regulatory, quality, clinical, reimbursement, and lab workstreams, and is differentiated into Integrated (SME) and Functional (enterprise) variants. The company has begun layering AI capabilities onto its traditional services: Lumo uses machine learning and neural network models trained on Jordi Labs' proprietary analytical data to improve quantitation accuracy in extractables and leachables assessments, and Fern.ai is an AI-enabled smart authoring module for regulatory documentation. Jordi Labs' chemical characterization methods are recognized by the FDA and frequently cited in regulatory guidance. RQM+ holds ISO 9001 certification, is an RAPS Premium Solutions Partner, and markets compliance with GDPR, CCPA, and ISO 13485 quality system standards.

The go-to-market motion is enterprise field sales targeting regulatory, quality, clinical, and executive decision-makers at MedTech companies globally, supplemented by thought leadership content (LinkedIn newsletter, podcast, resource library, webinars, industry conferences) and self-serve online portals for contractor matching and audit ordering. The customer base is concentrated in enterprise MedTech (large device and IVD manufacturers) but also includes mid-market and emerging MedTech startups seeking flexible, scalable support. The company is privately held, has 101-250 employees, and does not publicly disclose revenue or funding amounts.

Name

RQM+

Legal name

RQM+ Corporation

Website

https://rqmplus.com

Company type

Private

Founded year

2008

Operating status

Operating

Headcount range

101–250 employees

Short description

RQM+ is a full-service MedTech-only contract research organization providing integrated regulatory, quality, clinical trial, laboratory (via Jordi Labs), and reimbursement services to medical device and IVD companies across the US and Europe.

Ownership category

akta.pro rank

Product category

Medical Device Contract Research Services

NAICS

Scientific Research and Development Services (5417), Research and Development in the Physical, Engineering, and Life Sciences (54171), Management Consulting Services (54161), Custom Computer Programming Services (541511)

SIC

Services-Engineering, Accounting, Research, Management (8700), Services-Commercial Physical & Biological Research (8731), Services-Prepackaged Software (7372)

akta.pro primary industry

Clinical CROs (Phase I–IV) (HLAGAAAA)

akta.pro secondary industry

Clinical Data Management, Biostatistics & Statistical Programming CROs (HLAGAAAF)

Keywords

• Medical device CRO
• Regulatory consulting services
• Clinical trial management
• MedTech compliance services
• Extractables and leachables testing

Headquarters

HQ city

Monroeville

HQ country

United States

HQ region

North America

Offices6 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Marketing or Sales, Technology or R&D, Infrastructure

Revenue model

1. Regulatory & Quality Consulting: Regulatory strategy, quality management systems, FDA and EU MDR/IVDR compliance consulting, design controls, CAPA, complaints handling, and audit preparation services for medical devices and IVDs.
2. Clinical Trial Management & Execution: Full-service clinical trial management from early feasibility through pivotal and post-market studies, including project management, site management, data management, biostatistics, and medical writing. Services span across US, EU, Australia, and Latin America.
3. Laboratory & Material Science Testing: Jordi Labs provides analytical and chemical testing services including E&L analysis, biocompatibility testing, polymer deformulation, failure analysis, and toxicological assessments. Pricing is positioned as competitive with faster turnaround than industry norms.
4. Reimbursement Strategy Services: Reimbursement strategy development, payer research and gap analysis, health economics, market access roadmaps, coding and billing support for medical devices, diagnostics, and combination products.
5. Professional Staffing & Contract Placement: MedTech professional staffing and contract placement services, matching qualified contractors with specific project needs, timelines, and budgets through an automated database search.

Pricing tiers

Go-to-market motion2 records

Distribution channels3 records

Marketing channels8 records

Core offering

RQM+ is a full-service MedTech contract research organization (CRO) that delivers integrated regulatory affairs, quality systems, clinical trial management, laboratory/material science, and reimbursement services for medical device, IVD, combination product, and software-enabled medical product companies. The firm supports the entire product life cycle from concept through post-market under engagement models including full-service outsourcing, professional consulting, and staff augmentation. Its flagship SMART Solutions framework unifies all service areas, and AI-enabled platforms (Lumo, Fern.ai) plus the Jordi Labs chemical characterization lab round out the offering.

Product overview

RQM+ is a full-service MedTech CRO offering an integrated portfolio of regulatory consulting, clinical trial management, laboratory services, and reimbursement solutions. The core offering is SMART Solutions, a life cycle partnership model that unifies all service areas. Core services include Regulatory & Quality Services, Clinical Trials Services, and Reimbursement Services. Laboratory services are delivered through Jordi Labs (acquired in 2022), providing gold-standard chemical characterization and E&L testing. AI-enabled offerings include Fern.ai (smart authoring module) and Lumo (E&L risk clarification platform). Additional services include contractor matching and audit ordering.

Differentiator

Problem solved

Functional benefit

Brands

• Jordi Labs: Analytical lab and material science subsidiary specializing in chemical characterization, extractables and leachables testing, biocompatibility testing, and failure analysis for medical devices, pharmaceuticals, and consumer products. Recognized by the FDA as gold standard in E&L testing.
• SMART Solutions
• AcKnowledge Regulatory Strategies

Products and services

• SMART Solutions A life cycle partnership model that unifies regulatory, quality, clinical, reimbursement, and laboratory expertise to support MedTech companies throughout the entire product life cycle. Available in Integrated and Functional models.
• Regulatory & Quality Services Comprehensive regulatory affairs and quality assurance solutions including regulatory strategy, global submissions, quality system design, audits, and compliance guidance grounded in FDA and EU MDR/IVDR experience for medical device, IVD, and combination product companies.
• Clinical Trials Services End-to-end clinical trial management from early feasibility through post-market studies, including trial design, site management, data management, biostatistics, and medical writing, delivered across the U.S., Europe, Australia, and Latin America.
• Reimbursement Services Expert reimbursement strategy and market access solutions including coding, coverage, payer research and gap analysis, health economics, and market access roadmaps for medical devices, diagnostics, and combination products.
• Jordi Labs Laboratory Services Gold standard analytical laboratory providing chemical characterization, extractables and leachables (E&L) testing, biocompatibility assessments, polymer deformulation, unknown identification, and material science services. Recognized by the FDA as the gold standard in chemical characterization, with 60+ analytical techniques supported by Ph.D. analytical chemists.

Quantifiable outcome

• 50% efficiency gain achieved through proprietary technology platforms
• +6 more outcomes

Named customers6 records

Segments6 records

Ideal customer profiles5 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability3 records

Feature4 records

Partnerships

Four partnerships are on record, tiered core.

• CRO KottmanncoreStrategic or Co-development Partner · 27 August 2023RQM+ acquired German CRO Kottmann in August 2023 as part of its strategic growth in Europe and the MedTech industry. The acquisition expanded RQM+'s geographic footprint and enhanced client services in clinical research and product commercialization in the European market.
• Libra MedicalcoreStrategic or Co-development Partner · 10 May 2023RQM+ acquired Libra Medical in May 2023, a contract research organization specializing in early-stage clinical trials for medical devices and diagnostics. Libra operates studies across the US, Europe, Australia, and Latin America, providing regulatory affairs and clinical operations services.
• Jordi LabscoreStrategic or Co-development Partner · 7 September 2022RQM+ acquired Jordi Labs in September 2022 to expand its regulatory testing services, particularly extractables and leachables testing, biocompatibility, and chemical characterization for MedTech manufacturers. Jordi Labs is recognized by the FDA as the gold standard in chemical characterization and E&L testing.
• AcKnowledge Regulatory StrategiescoreStrategic or Co-development Partner · 1 January 2021RQM+ acquired AcKnowledge Regulatory Strategies (established 2014) in 2021 as part of its value creation plan to expand regulatory and quality consulting services and capabilities.

Scale indicators10 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• NAMSA: NAMSA is the longest-standing MedTech-focused CRO, offering regulatory, quality, clinical, and laboratory services to medical device manufacturers. It is the closest direct competitor to RQM+ across the same device-only service stack and customer base.
• Premier Research: Premier Research operates a MedTech-specialized clinical and regulatory CRO serving device and diagnostic sponsors. It directly competes with RQM+ on early-feasibility and pivotal medical device trials as well as regulatory strategy.

Broad incumbents

• IQVIA: IQVIA is the largest global CRO and competes across RQM+'s clinical, regulatory, and quality service lines through its MedTech and device practices. It serves overlapping enterprise medical device customers but as part of a much broader pharmaceutical-led portfolio.
• ICON plc: ICON is a global CRO with a dedicated medical device and diagnostics franchise. It competes with RQM+ for enterprise device and IVD clinical trial and regulatory work, but within a much wider biopharma-focused service portfolio.
• Parexel: Parexel is a large global CRO with a meaningful medical device practice. It bids against RQM+ for enterprise MedTech regulatory and clinical engagements alongside a much larger pharmaceutical services franchise.
• Charles River Laboratories: Charles River provides research, safety assessment, and manufacturing services and has expanded into MedTech adjacent testing and CRO services. It competes with RQM+'s lab and pre-clinical/clinical service lines from a far broader scientific services platform.
• Medpace: Medpace is a mid-to-large global CRO with growing MedTech clinical capabilities. It overlaps with RQM+ on device and IVD clinical trial execution but is not MedTech-specialized.
• Eurofins Scientific: Eurofins operates a large global network of testing laboratories including medical device, pharmaceutical, and consumer product testing. It competes most directly with RQM+'s Jordi Labs franchise on E&L, biocompatibility, and chemical characterization work.
• WuXi AppTec: WuXi AppTec is a large global CRO/CDMO with a growing medical device and diagnostics testing business. It competes with RQM+ on lab testing and clinical services for medical devices, particularly for sponsors seeking global delivery.

Regional players

• TÜV SÜD: TÜV SÜD is a major EU-based notified body and testing organization that influences the same EU MDR/IVDR regulatory process RQM+ supports. It is more of a regulatory gatekeeper and testing provider than a CRO, but competes for adjacent MedTech testing and certification spend.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat6 records

Key risks5 records

Key highlights6 records

Customer concentration

• Xx.com/RQMplus
• Facebookfacebook.com/sharer.php
• LinkedInlinkedin.com/company/rqmplus

Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles16 records

Subsidiaries4 records

Funding overview

Funding rounds1 record

Investors1 record

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A5 records

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about RQM+