MCRA Holdings Inc.

What MCRA Holdings Inc. does

MCRA Holdings Inc. (operating as MCRA, LLC and doing business as MCRA, an IQVIA business) is a Washington, DC-headquartered Clinical Research Organization (CRO) and advisory firm founded in 2004 by Viscogliosi Brothers, LLC. The company is purpose-built for the medical device, diagnostics, and biologics industry, integrating six "business value creators" — regulatory affairs, clinical research, reimbursement, healthcare compliance, quality assurance, and distribution logistics — into a single delivery model that takes MedTech clients from innovation conception through global commercialization. MCRA reports working with more than 850 MedTech companies annually on over 1,700 projects, with active engagements spanning 14+ therapeutic specializations including orthopedics, spine, cardiovascular, neurology, biologics, wound care, imaging and robotics, digital health, in-vitro diagnostics, and cell and gene therapy.

MCRA's product surface comprises 14+ service lines, organized into core and specialized offerings. Core services include the Global CRO, FDA Regulatory, Europe Regulatory, Japan Regulatory (delivered via MCRA Japan), Reimbursement/Health Economics & Market Access (RHEMA), Quality Assurance, Healthcare Compliance, and Talent Solutions. Specialized services include the AI & Imaging Center, Cybersecurity Solutions for Medical Devices, Digital Health Program (covering SaMD/SiMD), Statistical Analysis, Biocompatibility, and Human Factors. The business model is professional services — fee-for-service consulting and project-based engagements delivered directly to enterprise MedTech clients — with no publicly disclosed pricing or contract terms. Distribution is direct enterprise sales via offices in Washington DC, Hartford CT, New York NY, and Tokyo, supported by content marketing, case studies, webinars, and a newsletter funnel.

The company is privately held and operates as a subsidiary of IQVIA (NYSE:IQV), the global life sciences analytics and CRO platform. In March 2022, MCRA acquired Vorpal Technologies K.K. (now MCRA Japan), a Tokyo-based MedTech consulting firm founded in 2013, establishing a regional headquarters in Japan with D-MAH services, shonin approvals expertise, and reimbursement category listings. Senior leadership includes David Lown (President), Samuel Pollard (General Manager, MCRA Japan), Alex Cadotte Ph.D. (VP, Digital Health/AI/Radiology Regulatory Affairs), and dedicated Directors across Digital Health, Cybersecurity, Clinical Affairs, and Imaging Operations.

Name

MCRA Holdings Inc.

Legal name

MCRA, LLC

Website

https://mcra.com

Company type

Private

Founded year

2004

Operating status

Operating

Short description

MCRA is a US-headquartered medical device CRO and advisory firm, integrating regulatory, clinical research, reimbursement, compliance, quality, and distribution services to support 850+ MedTech companies annually across the US, Europe, and Japan.

Ownership category

akta.pro rank

Product category

Medical Device CRO & Regulatory Consulting

NAICS

Scientific Research and Development Services (5417), Other Scientific and Technical Consulting Services (54169), Management Consulting Services (54161)

SIC

Services-Management Consulting Services (8742), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Specialty Therapeutic-Area CROs (e.g., oncology/rare disease) (HLAGAAAL)

akta.pro secondary industries

Clinical Quality Assurance (GCP QA, TMF/QMS oversight) (HLAGAKAI), Clinical CROs (Phase I–IV) (HLAGAAAA)

Keywords

• Medical device CRO
• Regulatory consulting
• Clinical research services
• Reimbursement strategy
• Healthcare compliance 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, Infrastructure, Others

Revenue model

1. CRO Services: Global Clinical Research Organization services providing clinical trial operations and regulatory affairs support for medical devices, diagnostics, and biologics.
2. Regulatory Consulting: FDA Regulatory Consultant services, Europe Regulatory, Japan Regulatory Medical Device Consultants, and Global Regulatory services.
3. Reimbursement Services: Medical Device Reimbursement, Health Economics & Market Access (RHEMA) services.
4. Quality Assurance & Healthcare Compliance: Quality Assurance, Healthcare Compliance, Cybersecurity Solutions for Medical Devices services.
5. Specialized Services: Biocompatibility Services, Statistical Analysis for Medical Devices, Human Factors and Usability Engineering, Talent Solutions, and AI & Imaging Center services.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels7 records

Core offering

MCRA is a full-service Clinical Research Organization (CRO) and advisory firm for medical device, diagnostics, and biologics companies, delivering integrated consulting across six business value creators: regulatory affairs, clinical research, reimbursement/health economics & market access, healthcare compliance, quality assurance, and distribution logistics. The firm guides clients from innovation conception through global commercialization, with particular depth in FDA, European, and Japanese regulatory pathways, including De Novo grants, 510(k) clearances, and Shonin approvals.

Product overview

MCRA Holdings Inc., an IQVIA business, operates as a leading medical device, diagnostics, and biologics Clinical Research Organization (CRO) and advisory firm. The company offers integrated consulting services through its six core business value creators: regulatory affairs, clinical research, reimbursement, healthcare compliance, quality assurance, and distribution logistics. Key service offerings include Global Clinical Research Organization (CRO), FDA Regulatory Consultant, Europe Regulatory, Japan Regulatory Medical Device Consultants, Reimbursement Health Economics & Market Access (RHEMA), Quality Assurance, AI & Imaging Center, Talent Solutions, Cybersecurity Solutions, Digital Health Program, Statistical Analysis for Medical Devices, Biocompatibility Services, Healthcare Compliance, and Human Factors. MCRA works with more than 850 companies in the MedTech industry annually on more than 1700 projects. The company maintains offices in Washington, DC, Hartford, CT, New York, NY, and Tokyo, Japan.

Differentiator

Problem solved

Functional benefit

Products and services

• Global Clinical Research Organization (CRO) Full-service CRO offering clinical trial design, execution, and management for medical devices, diagnostics, and biologics across multiple therapeutic areas, intended for medical device manufacturers seeking clinical evidence for regulatory submissions.
• FDA Regulatory Consultant
• Europe Regulatory
• Japan Regulatory Medical Device Consultants Regulatory and clinical consulting for Japan market entry, including Shonin approvals and reimbursement strategy, delivered through MCRA Japan (Vorpal Technologies K.K.).
• Reimbursement, Health Economics & Market Access (RHEMA)
• Quality Assurance
• AI & Imaging Center
• Talent Solutions
• Cybersecurity Solutions for Medical Devices
• Digital Health Program
• Statistical Analysis for Medical Devices
• Biocompatibility Services
• Healthcare Compliance
• Human Factors and Usability Engineering

Quantifiable outcome

• More than 850 MedTech companies served annually on more than 1700 projects
• +2 more outcomes

Named customers14 records

Segments5 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

One partnership is on record.

• Vorpal Technologies K.K.coreOthersAcquired in March 2022, Vorpal is the premier MedTech consulting firm for Japan and leader in new regulatory approvals. Founded in 2013 and headquartered in Tokyo, Vorpal is a full-service virtual subsidiary enabling international MedTech innovators to enter the Japanese market. MCRA announced Samuel Pollard as General Manager of Vorpal following the acquisition.

Scale indicators7 records

Recent moves6 records

Expansion highlights6 records

Broad incumbents

• IQVIA: IQVIA is MCRA's parent company and one of the largest global CROs; its broader life sciences clinical and technology platforms both support and compete with MCRA's specialty device franchise within the same corporate portfolio.
• Charles River Laboratories: Charles River is a large CRO/CDMO with a growing medical device and diagnostics practice, including preclinical and clinical research services. It competes with MCRA for device sponsors seeking integrated research support.
• Medpace: Medpace is a mid-to-large global CRO with a growing medical device and diagnostics franchise alongside its core biopharma business. It competes with MCRA on device clinical trials while offering much broader scale and full-service capabilities.
• Parexel: Parexel is a global full-service CRO with significant medical device experience and regulatory consulting capabilities, competing with MCRA for device sponsor engagements across clinical and regulatory phases.

Direct peers

• Premier Research: Premier Research operates a dedicated MedTech and specialty CRO practice with regulatory, clinical, and reimbursement services for medical device and diagnostic sponsors. It overlaps directly with MCRA across device regulatory strategy and clinical trial execution.
• NAMSA: NAMSA is the largest independent medical device-focused CRO, providing regulatory, clinical, and laboratory services to MedTech companies globally. It is the closest direct competitor to MCRA across the same device-focused regulatory and clinical value chain.

Emerging players

• Worldwide Clinical Trials: Worldwide Clinical Trials is a mid-sized CRO with growing medical device and rare disease focus, providing clinical and regulatory services that overlap with MCRA's device-focused offering.
• RCRI (Regulatory & Clinical Research Institute): RCRI is a smaller, MedTech-specialized CRO offering regulatory affairs, clinical trial management, and quality services to medical device companies. It is a comparable niche competitor to MCRA in the device regulatory space.
• Boston Biomedical Associates (BBA): BBA is a boutique MedTech-focused CRO providing clinical operations, regulatory affairs, and quality assurance to device companies. It competes with MCRA in the same specialty CRO segment, particularly for smaller device sponsors.

Others

• Veeva Systems: Veeva provides cloud-based software (Vault) for regulatory, clinical, and quality operations in life sciences, including MedTech. It is an enabling technology partner/adjacent competitor to MCRA's regulatory and QA services rather than a direct CRO.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat6 records

Key risks5 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/mcra

Revenue estimate

Valuation estimate

Number of profiles

Profiles8 records

Subsidiaries1 record

Funding overview

Funding rounds

Investors

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

M&A

Investments

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

Frequently asked questions about MCRA Holdings Inc.