MCRA
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.
- Company typePrivate
- Founded2004
- HeadquartersWashington, United States
- Headcount51–100
- GTM typeB2B
- OfferingServices
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).
MCRA firmographics
Firmographics- 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
MCRA industry classification
Industry- 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
Where MCRA is headquartered
LocationHeadquarters
- HQ city
- Washington
- HQ country
- United States
- HQ region
- North America
Offices4 records
Markets served
MCRA business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Technology or R&D, Marketing or Sales, Others
Revenue model
- 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.
- 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.
- Reimbursement, Health Economics & Market Access (RHEMA): Reimbursement, health economic, and market access professionals guide healthcare companies through the complex dynamics in medical technology commercialization.
- Quality Assurance Services: FDA and global quality assurance requirements to ensure product consistency and safety.
- Healthcare Compliance Services: Corporate Compliance Program support for healthcare organizations and medical device companies.
- Cybersecurity Solutions: Full integrated services to secure and protect medical device or Software as a Medical Device solutions.
- 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
MCRA product offering
Product offeringCore 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
Companies that use MCRA
Customer profileNamed customers14 records
Segments4 records
Ideal customer profiles3 records
MCRA technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature2 records
MCRA partnerships and signals
Strategic signalPartnerships
Three partnerships are on record, tiered core and flagship.
- NexsencoreNexsen 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.
- OrthobondcoreIn 2024 MCRA partnered with Orthobond to achieve FDA De Novo clearance for the Mariner Pedicle Screw System with Ostaguard coating.
- IQVIAflagshipMCRA, 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
MCRA competitors and assessment
Company assessmentDirect 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
MCRA social profiles
Digital presenceMCRA financial estimates
Financial estimateRevenue estimate
Valuation estimate
MCRA leadership team
Management profileNumber of profiles
Profiles24 records
MCRA funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
MCRA M&A and investment
M&A and investmentM&A1 record
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about MCRA
What does MCRA do?
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.
Is MCRA a public or private company?
MCRA is a private company. It is classified as corporate owned and is currently operating.
When was MCRA founded?
MCRA was founded in 2004. It employs 51 to 100 people.
Where is MCRA based?
MCRA is headquartered in Washington, United States, in the North America region.
How does MCRA make money?
Seven revenue lines are on record. Clinical Research Organization (CRO) Services are the primary driver. The others are FDA Regulatory Consulting, reimbursement, Health Economics & Market Access (RHEMA), quality Assurance Services, healthcare Compliance Services, cybersecurity Solutions and talent Solutions.
Who are MCRA's main competitors?
Direct peers on record are Avania, Premier Research, Biorasi, NAMSA and Clinipace Worldwide. Broad incumbents are ICON plc, IQVIA, Charles River Laboratories, Syneos Health and Medpace.
Does MCRA have an API?
No public API is recorded for MCRA.
What industry is MCRA in?
MCRA's product category is Medical Device CRO & Regulatory Consulting. Its primary akta.pro industry code is HLAGAAAA, Clinical CROs (Phase I–IV), with a secondary code of HLAGAAAF, Clinical Data Management, Biostatistics & Statistical Programming CROs. Its NAICS code is 5417.