Veranex

Name

Veranex

Legal name

Veranex Inc.

Website

https://veranexsolutions.com

Company type

Private

Founded year

2021

Operating status

Operating

Ownership category

akta.pro rank

Product category

Medical Device Contract Research Services

NAICS

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

SIC

Services-Commercial Physical & Biological Research (8731), Services-Testing Laboratories (8734)

akta.pro primary industry

Regulatory Strategy & Global Submissions (IND/CTA/NDA/BLA/MAA) (HLAGAKAA)

akta.pro secondary industries

Quality Engineering & Risk Management (ICH Q9/Q10, validation, change control) (HLAGAKAL), Healthcare & Clinical Professional Development (CME/CE) (EDAGANAJ)

Keywords

• Medical device development
• Preclinical contract research
• Clinical research organization
• Regulatory affairs consulting
• Medical device commercialization

Headquarters

HQ city

Raleigh

HQ country

United States

HQ region

North America

Offices13 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Professional Services - Medical Device Development: Integrated contract research services for medical device development spanning design & development, preclinical research, clinical trials, regulatory affairs, quality consulting, and commercialization support. Revenue generated through project-based engagements and service contracts with medical technology companies.
2. Training and Certification Programs: Instructor-led training programs for FDA inspection readiness, ISO 13485 quality management, MDR compliance, and regulatory affairs certification. Delivered in partnership with TÜV SÜD Academy. Revenue from course fees.

Pricing tiers

Go-to-market motion1 record

Distribution channels4 records

Marketing channels7 records

Core offering

Veranex operates as an integrated Contract Research Organization (iCRO) for medical devices and in-vitro diagnostics, providing product design and engineering, preclinical and pathology research, clinical trials, regulatory affairs, quality consulting, manufacturing, and market access/commercialization services under a single accountable organization. The company serves medical device innovators, IVD developers, and biopharma sponsors across the full product lifecycle from concept through commercialization.

Product overview

Veranex operates as an integrated Contract Research Organization (iCRO) that unifies multiple specialized services for medical device and in vitro diagnostic development. The company offers a comprehensive suite of services including Design & Development, Preclinical & Pathology, Clinical Research, Regulatory Consulting, Quality Consulting, Commercialization, and Manufacturing Solutions. These services are connected through an integrated model that enables cross-disciplinary expertise from concept through commercialization. The company also offers specialized solutions in Biocompatibility, Digital Health, Technical Writing, and Training Programs, with a dedicated Biopharma sub-brand for pharmaceutical development support. Veranex serves clients across therapeutic areas including Cardiovascular, In-vitro Diagnostics, Neurology, and Ophthalmology.

Differentiator

Problem solved

Functional benefit

Brands

• Veranex Biopharma: Extends the integrated iCRO model to support pharmaceutical and biologics development, offering expertise in clinical research, regulatory strategy, and commercialization for drug and biologic therapies.

Products and services

• Design & Development Comprehensive product design and engineering services for medical device developers spanning research and strategy, product design, software development, engineering and development, testing and prototyping, human factors engineering, and manufacturing solutions.
• Preclinical & Pathology GLP and non-GLP preclinical research services for medical device testing in animal models, including pathology, surgical and bioskills training, cadaver lab, and dedicated preclinical facilities.
• Clinical Research (CRO) Full-service medical device clinical research organization covering trial design, trial management, project management, study monitoring, safety management, data management, biostatistics and programming, data visualizations, and medical writing.
• Regulatory Consulting Regulatory affairs consulting covering FDA device consulting, EU MDR consulting, EU IVDR consulting, and authorized representative services to support medical device and IVD market access.
• Quality Consulting Quality management system consulting for medical device manufacturers including audit and inspection readiness, QMS consulting, design validation and quality, and special process validation.
• Commercialization Market access and commercialization services for medical devices including innovation and strategy, market and customer insights, access and reimbursement, HEOR consulting, and integrated evidence planning.
• Manufacturing Solutions Medical device contract manufacturing services delivered from early development through full commercial builds with scalable production volumes.
• Biocompatibility Testing Biocompatibility testing services for medical devices performed in alignment with ISO 10993 standards.
• Digital Health Solutions Digital health technology consulting and development services for connected medical devices and software-as-a-medical-device (SaMD).
• Technical Writing Medical and regulatory technical writing services for medical devices and in vitro diagnostics.
• Training Programs Professional training programs for medtech professionals including TÜV SÜD certification training, preclinical training, and broader training curriculum covering ISO 13485, EU MDR, FDA inspection readiness, and regulatory affairs.
• Veranex Biopharma Pharmaceutical and biologics development services that extend Veranex's integrated iCRO model to drug development, including clinical research, regulatory strategy, and commercialization support.

Quantifiable outcome

• 1000+ programs accelerated for 700+ global clients
• +3 more outcomes

Named customers2 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

Feature3 records

Partnerships

Three partnerships are on record, tiered major and core.

• Recross CardiomajorStrategic or Co-development Partner · 3 December 2025Veranex conducted GLP preclinical studies (28-day and 90-day post-implantation) for Recross Cardio's PFO Sealing Technology. Studies generated safety and performance evidence that supported FDA approval for first-in-human PROTEA-PFO Early Feasibility Study.
• TÜV SÜD AcademycoreStrategic or Co-development PartnerTraining partnership delivering certification programs for ISO 13485 quality management (Quality Specialist, Quality Representative, Quality Auditor), MDR Expert certification, and regulatory affairs training. TÜV SÜD provides the exam and certificate pathway while Veranex delivers applied training content.
• Tufts Medical CentermajorStrategic or Co-development PartnerClinical trial site for PROTEA-PFO Early Feasibility Study. Dr. Carey Kimmelstiel, Director of Interventional Cardiology and National Co-Principal Investigator, performed the first successful implantation.

Scale indicators9 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• NAMSA: NAMSA is the largest CRO dedicated exclusively to medical devices and IVDs, offering preclinical, clinical, regulatory, and quality consulting globally. It is the closest direct competitor to Veranex's iCRO model in therapeutic focus and integrated service bundle.
• RCRI (Rover Clinical Research International): RCRI is a medical device-focused CRO providing clinical trial management, biostatistics, and regulatory services for cardiovascular and structural heart devices. It is comparable to Veranex in therapeutic focus and integrated device clinical offering.
• Emergo (by UL): Emergo by UL provides regulatory affairs, quality systems, and clinical evaluation consulting specifically for medical devices and IVDs. It overlaps directly with Veranex's regulatory and quality consulting practice and serves similar medtech and IVD clients.

Broad incumbents

• Charles River Laboratories: Charles River is a global, publicly traded CRO with significant preclinical, safety assessment, and discovery services that overlaps with Veranex's preclinical and pathology offerings. It is broader than Veranex but competes for the same device and IVD sponsor preclinical spend.
• IQVIA: IQVIA is the largest global CRO and life sciences technology provider with extensive clinical research, real-world evidence, and regulatory capabilities. While pharma-heavy, it increasingly competes for device and IVD sponsors seeking integrated development services.
• ICON plc: ICON is a major global CRO with strong medical device and diagnostics clinical research capabilities acquired through Symphony Health and other transactions. It competes for the same clinical and integrated development budgets as Veranex.
• Medpace: Medpace is a mid-to-large CRO with a strong therapeutic-area operating model that overlaps with Veranex's therapeutic specialization across cardiovascular, neurology, and ophthalmology device development.
• Parexel International: Parexel is a large global CRO with a dedicated Medical Devices and Diagnostics group offering regulatory, clinical, and market access services. It competes with Veranex for integrated medtech development mandates.
• WuXi AppTec: WuXi AppTec is a global CRO/CDMO with preclinical, clinical, and regulatory services relevant to medtech sponsors operating internationally. It represents a scaled, lower-cost competitor for portions of Veranex's preclinical and clinical work.

Regional players

• DEKRA Certificación: DEKRA is a global testing, inspection, and certification organization with medical device Notified Body services, ISO 13485 certification, and regulatory consulting. It overlaps with Veranex's quality, certification, and EU Authorized Representative services.

Market position

Strengths5 records

Weaknesses4 records

Competitive moat5 records

Key risks4 records

Key highlights6 records

Customer concentration

• Xx.com/veranex
• YouTubeyoutube.com/veranex
• Facebookfacebook.com/veranex
• LinkedInlinkedin.com/company/veranex
• Instagraminstagram.com/veranex

Compliance14 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles14 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 Veranex