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Turn Vision into Velocity with the Innovation CRO

Traditional CROs fragment device development with costly hand-offs and learning curves. Veranex unites the essential disciplines for medical device & diagnostic development under one roof from sketch to evidence-generation to market launch.

All connected. All aligned. All accelerating your path to market—delivering breakthrough devices and diagnostics that improve patient lives sooner.

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Outcome-Driven Solutions for Medtech Challenges

Breakthrough innovation requires more than great solutions; it demands deep expertise and insight. Veranex packages outcome-driven solutions with 25+ years of specialized knowledge across major medtech categories, delivering integrated capabilities that solve your most pressing challenges faster and with greater certainty.

Purpose-built solutions. Proven results. User & Patient-centered innovation.

 

Solutions

Expertise

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Purpose-Built for Breakthroughs

Whether you're transforming patient care or disrupting entire therapeutic categories, innovation requires more than great science, it demands velocity.  Veranex was founded to bridge the gap between visionary concepts and market reality, combining proven expertise with agile execution to accelerate the innovations that matter most.  

We are the Innovation CRO.

Legacy of excellence. Proven execution. Patient impact accelerated.

 

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Your Trusted Cardiovascular Medical Device CRO

From Concept to Commercialization

Powering cardiovascular device innovation with $30B+ enterprise value delivered for MedTech leaders in the last 5 years.

Cardiovascular CRO Expertise Driving Device Innovation

At Veranex, cardiovascular device innovation isn’t just a focus — it’s our passion.

With over $30B in enterprise value created for our partners, we bring unparalleled expertise to every project. Backed by 20+ years of experience supporting MedTech leaders, we’ve played a pivotal role in advancing groundbreaking cardiovascular devices that save lives and shape the future of healthcare. From first-in-class innovations to next-generation improvements, we’ve partnered with sponsors across every stage of development, ensuring success from concept to commercialization.
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Cardiovascular Device Expertise

Last 3 years, by the numbers...
136

Design & Engineering Projects

130
+

Cardiovascular Patents Secured

596

Preclinical Studies

90
%

TAVI/TAVR Valves Validated

198

Regulatory & Quality Projects

64

Clinical Investigations

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What Clients Say

"Since we launched our redesigned TAVR handle, which was supported by Veranex’s design and engineering teams, we’ve seen that the performance of the valve itself has improved."

R&D Director, Large Medtech

What Clients Say

"[With Veranex preclinical] we’ve successfully transformed two groundbreaking concepts from napkin sketches into viable products in structural heart care. One product is now commercially available and the next is on the path to approval."

CTO at a Small Medtech Company

What Clients Say

"Veranex [Regulatory & Quality] gave us confidence that the extra steps were worth it. Their expertise gave us guardrails and then they empowered us to make the right business decisions, which was invaluable."

VP of Marketing, Small Medtech

Seamless Solutions for Every Stage of Your Cardiovascular Device Journey

From Generation 1 to Generation 3 and Beyond, We’re Your Partner at Every Milestone.


Veranex is the only MedTech CRO that integrates design, manufacturing, preclinical, and clinical investigation capabilities—guided by regulatory & commercialization expertise—to advance your cardiovascular device from concept to commercialization. By offering seamless transitions within a single partner, we eliminate inefficiencies, save valuable time, and reduce costs—enabling our sponsors, like you, to focus on innovation that transforms patient care.

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Product Design & Engineering

From idea to market-leading solution, our Product Design & Engineering team delivers innovative cardiovascular solutions, seamlessly integrating the disciplines of research, industrial design, human factors, and manufacturing to transform your healthcare innovation into reality.

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Preclinical Solutions

Building on our innovative designs, Veranex’s world-class preclinical facilities in Atlanta, Worcester, and Paris set the gold standard in cardiovascular research and histopathology—delivering insights that drive success and accelerate your path to market.

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Regulatory & Quality Systems

Serving at the hub of Veranex’s integrated approach, our Regulatory & Quality Systems team provides strategic value at every stage of development. From regulatory consultations and submissions to streamlining compliance, we ensure your cardiovascular device reaches the market with confidence and precision.

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Clinical Investigations

Bridging innovation to evidence, our Clinical Investigations CRO team supports every stage of cardiovascular medical device trials. From delivering high-quality data to flawless execution, we advance your device towards regulatory approval and transformative patient impact.

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Commercial Strategy & Market Access

From early development to launch, our Commercial Strategy & Market Access team identifies pathways to success. By aligning product design with market needs, regulatory goals, and clinical milestones—including pricing and reimbursement strategies—we help position your cardiovascular device for optimal success in competitive markets.

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Your partners in cardiovascular device innovation
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Silvia Anghel

Senior Director, Quality and Regulatory Affairs
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Luc Behr, DVM, PhD

Senior Vice President, Scientific Director, Preclinical
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Bob Bouthillier

Director, Electrical Engineering
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Nicolas Borenstein, DVM, PhD

Senior Vice President, Scientific Director, Preclinical
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Lisa Boyle

Chief Innovation Officer
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Irena Brants

Senior Preclinical Study Director
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Olivier Chevènement, DVM, PhD

Director of Preclinical Veterinary Research
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Joseph Ferrara

Chief Strategy Officer
 
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Ramona Field

Senior Director, Quality Systems
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Dustin Gaidos

Director, Product Development Program Manager
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Genice Gallegos

Vice President, Clinical Affairs, US
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Joe Gordon

Vice President, Innovation & Technology
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Danita Harris

Senior Vice President, Clinical Data Services
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Valentina Lintas

Quality and Regulatory Affairs Manager
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Cinzia Metallo

Director, Product Commercialization
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Alexis Morlet, DVM, PhD

Director of Preclinical Veterinary Research
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Michael Neidert

Vice President Strategic Development
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Jérôme Randall

Scientific Affairs Manager
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Cédric Razaname

Director, Quality and Regulatory Affairs
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Timothy Sheflin

Vice President, Commercial Strategy and Market Access
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Brad Solberg

Senior Director, Clinical Affairs
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Michael Sweet

Director of Preclinical Study Management

Discover the iCRO: The Innovation Contract Research Organization

Quality excellence begins in the design phase, not after your device is built. Traditional siloed approaches create costly iterations between product development, quality validation, regulatory approval, and clinical execution. Our integrated team ensures quality-first design accelerates regulatory strategy, clinical performance, and commercial potential from day one.

Case Studies

Impactful Innovations & Results

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TAVI Delivery System

 

Situation

In response to evolving market demands due to increasing prevalence of aortic stenosis disorder, our client was determined to improve their transcatheter aortic valve implantation device (TAVI) to become the preferred standard by surgeons.

Successes

  • 175 initial concepts generated, reduced to 5 compelling directions that lead to the 1 selected delivery system.
  • We harvested thought leader and end user feedback from multiple geographies (US, Germany, and Netherlands) to inform sponsor and solution positioning to drive market competitiveness.
  • Veranex produced rapid prototypes with benchtop testing, to expedited development of final fit and form, leading to best-in-class solution that is gaining market share today.
  • 16 months from project initiation to design freeze

 

Services by Veranex

  • Early discovery
  • Product design ideation
  • Rapid prototyping and testing
  • Human factors and usability testing
  • Product design refinement

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Pulse Field Ablation Preclinical Study

 

Situation

A large-animal model GLP preclinical study was needed to support a 510(k) submission for the next generation of an electrophysiology (EP) device, specifically with pulsed field ablation (PFA).

Successes

  • The sponsor leveraged Veranex’s PFA expertise to design and execute a large-animal GLP study.
  • We leveraged our in-house DVM to guide execution and delivery of the PFA in model supporting sponsor's staff.
  • Safety criteria was met and summarized into a report after a 30-day checkup and histopathology results.

 

Services by Veranex

  • Preclinical Services | Paris, France
  • Preclinical Services | Atlanta, GA
  • Histology | Worcester, MA

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TAVR Preclinical Study

 

Situation

TAVR is known to migrate in animals, we created an ovine model of aortic calcification to support TAVR.

Successes

  • The team leveraged their expertise to execute a cardiopulmonary bypass open-heart approach to perform annuloplasty that spared the native aortic leaflets. Two weeks later the TAVR was successfully completed.
  • Leveraged in house DVM to support the Sponsor’s staff to execute study.
  • The data collected demonstrated chronic performance of the valve and the acute performance of the delivery system to support an FDA submission.

 

Services by Veranex

  • Preclinical Services | Paris, France

Need an expert opinion?

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