MCRA

What MCRA does

MCRA is a privately held, full-service Clinical Research Organization (CRO) and consulting advisory firm focused exclusively on medical devices, diagnostics, and biologics. Founded in 2004 and operating as a subsidiary of IQVIA (NYSE:IQV), MCRA integrates six core service lines — clinical research, FDA regulatory consulting, reimbursement/health economics/market access (RHEMA), quality assurance, healthcare compliance, and cybersecurity — into a single platform that supports clients from pre-clinical through post-commercialization. The firm also offers specialized practices including an AI & Imaging Center, biocompatibility, biostatistics, human factors, and talent/staffing solutions, and delivers therapy-specific expertise across orthopedics, spine, cardiovascular, neurology, biologics, IVD, digital health, imaging & robotics, and cell & gene therapy.

MCRA's business model is professional services / project-based, with quote-based B2B pricing, no publicly disclosed fees, and revenue derived from engagements across 850+ MedTech companies and 1,700+ projects annually. Its customer base spans early-stage device developers, global manufacturers, and financial investors, with documented FDA approvals and clearances across PMA, De Novo, 510(k), and breakthrough device pathways. The company maintains offices in Washington D.C. (headquarters), New York City, Hartford CT, and Tokyo, and is led by President David W. Lown with a senior team that includes multiple former FDA Branch Chiefs and therapy-specialized VPs. MCRA acquired Vorpal Technologies in March 2022 to expand its technology footprint, and continues to add therapy-vertical capabilities through senior hires and client engagements (e.g., Nexsen partnership in November 2025).

Name

MCRA

Legal name

MCRA

Website

https://mcra.com

Company type

Private

Founded year

2004

Operating status

Operating

Headcount range

51–100 employees

Short description

MCRA is a privately held, IQVIA-owned CRO and advisory firm founded in 2004 that provides integrated clinical research, FDA regulatory, reimbursement, quality, compliance, and cybersecurity services to medical device, diagnostics, and biologics companies globally.

Ownership category

akta.pro rank

Product category

Medical Device CRO & Regulatory Consulting

NAICS

Scientific Research and Development Services (5417), Research and Development in the Physical, Engineering, and Life Sciences (54171), Other Scientific and Technical Consulting Services (54169)

akta.pro primary industry

Clinical CROs (Phase I–IV) (HLAGAAAA)

akta.pro secondary industries

Clinical Data Management, Biostatistics & Statistical Programming CROs (HLAGAAAF), Clinical Quality Assurance (GCP QA, TMF/QMS oversight) (HLAGAKAI), Specialty Therapeutic-Area CROs (e.g., oncology/rare disease) (HLAGAAAL)

Keywords

• Medical device CRO
• FDA regulatory consulting
• Clinical research services
• Medical device reimbursement
• Biologics advisory

Headquarters

HQ city

Washington

HQ country

United States

HQ region

North America

Offices4 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Clinical Research Organization (CRO) Services: Global medical device CRO enabling companies of all sizes to successfully execute clinical studies by streamlining the clinical trial process through an integrated approach that guides clients through the medical device lifecycle: from pre-clinical testing, to regulatory submission, market approval, and post commercialization.
2. FDA Regulatory Consulting: U.S. Regulatory Advisor for Medical Device and Biologics industries providing strategies for all FDA submissions including PMA, De Novo, 510(k), and breakthrough designations.
3. Reimbursement, Health Economics & Market Access (RHEMA): Reimbursement, health economic, and market access professionals guide healthcare companies through the complex dynamics in medical technology commercialization.
4. Quality Assurance Services: FDA and global quality assurance requirements to ensure product consistency and safety.
5. Healthcare Compliance Services: Corporate Compliance Program support for healthcare organizations and medical device companies.
6. Cybersecurity Solutions: Full integrated services to secure and protect medical device or Software as a Medical Device solutions.
7. Talent Solutions: Full suite of staffing and recruiting services across all MedTech and Life Science specialties.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

MCRA is a full-service Contract Research Organization (CRO) and consulting advisory firm for the medical device, diagnostics, and biologics industries. It integrates six core service lines — clinical research, FDA regulatory, reimbursement/health economics/market access, quality assurance, healthcare compliance, and cybersecurity — to guide clients from innovation conception through FDA approval, market access, and post-commercialization. Additional specialized offerings include an AI & Imaging Center, global regulatory services in Europe and Japan, biostatistics, biocompatibility, human factors, and talent/staffing solutions.

Product overview

MCRA is a leading global full-service medical device, diagnostics, and biologics CRO and consulting advisory firm. The company operates as a unified platform integrating six core business value creators: clinical research organization services, FDA regulatory consulting, reimbursement and market access, quality assurance, healthcare compliance, and cybersecurity solutions. Founded in 2004, MCRA works with more than 850 companies in the MedTech industry annually on over 1700 projects. The integrated service model combines regulatory expertise with clinical trial execution, reimbursement strategy, and commercialization support. Additional specialized services include an AI & Imaging Center for AI/ML-enabled devices, statistical analysis, biocompatibility services, talent solutions, and human factors engineering. The company has therapy specializations across orthopedics, spine, cardiovascular, wound care, biologics, neurology, imaging & robotics, digital health, in-vitro diagnostics, and cell and gene therapy. MCRA is an IQVIA business with offices in New York City, Washington, D.C., Hartford, CT, and Tokyo.

Differentiator

Problem solved

Functional benefit

Products and services

• Global Clinical Research Organization (CRO)

Quantifiable outcome

• FDA clearance achieved for United Imaging Intelligence Technology in under 60 days
• +1 more outcomes

Named customers14 records

Segments4 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature2 records

Partnerships

Three partnerships are on record, tiered core and flagship.

• NexsencoreStrategic or Co-development Partner · 6 November 2025Nexsen appointed MCRA to expedite its U.S. market entry for its GBS Rapid Sensor and Kidney Function Diagnostics. MCRA will advise on FDA regulatory pathways and market access, with the first FDA interaction expected in early 2026.
• OrthobondcoreStrategic or Co-development PartnerIn 2024 MCRA partnered with Orthobond to achieve FDA De Novo clearance for the Mariner Pedicle Screw System with Ostaguard coating.
• IQVIAflagshipOthersMCRA, an IQVIA business, is a leading medical device, diagnostics, and biologics Clinical Research Organization (CRO) and advisory firm. MCRA integrates with IQVIA's global network of analytics, technology solutions and contract research services.

Scale indicators3 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Avania: Medical-device-focused CRO offering clinical research, regulatory, and reimbursement services. Highly comparable to MCRA's integrated med-device CRO+advisory model.
• Premier Research: Mid-size CRO with strong medical-device and specialty therapeutics practices. Competes with MCRA for device clinical trials, regulatory submissions, and pediatric/rare-disease programs.
• Biorasi: CRO with medical-device and specialty therapeutics practices. Competes with MCRA for regulatory and clinical services from emerging med-device sponsors.
• NAMSA: Specialized medical-device CRO providing regulatory, clinical, and quality consulting. The most direct competitor to MCRA in medical-device-focused CRO and FDA regulatory advisory.
• Clinipace Worldwide: Mid-size CRO serving medical-device, biotech, and pharma sponsors. Directly competes with MCRA for clinical-trial execution and regulatory submissions in the mid-market segment.

Broad incumbents

• ICON plc: Top-five global CRO with significant medical-device and diagnostics exposure. Competes with MCRA on multi-region device trials and FDA regulatory submissions at greater scale.
• IQVIA: Parent company and largest global life-sciences CRO. Overlaps directly with MCRA's clinical research and regulatory services but operates across pharma, biotech, and medical devices at much greater scale and broader geography.
• Charles River Laboratories: Large CRO with a medical-device solutions division. Competes with MCRA on device safety, biocompatibility, and FDA regulatory services from a broader life-sciences platform.
• Syneos Health: Global CRO with medical-device and diagnostics capabilities. Overlaps with MCRA on clinical operations and regulatory consulting for med-device sponsors.
• Medpace: Mid-to-large global CRO with growing medical-device and diagnostics practice. Competes with MCRA on full-service clinical execution and regulatory support for device sponsors.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/mcraresources
• LinkedInlinkedin.com/company/mcra

Revenue estimate

Valuation estimate

Number of profiles

Profiles24 records

Funding overview

Funding rounds

Investors

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

M&A1 record

Investments

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

Frequently asked questions about MCRA