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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.

 

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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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Veranex Blog

FDA Regulatory

6 min read

The WISeR Model: What Medical Device Manufacturers Need to Know Right Now

Picture of Tim Shefflin Tim Shefflin: Oct 29, 2025 8:54:17 AM
FDA Regulatory Commercialization Regulatory
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4 min read

The Hidden Cost of Failure to Apply Human Factors and Usability Engineering to Medical Devices: Why Your Clinical Trial Budget May Double

Picture of Nick Benedetto Nick Benedetto: Oct 22, 2025 8:26:10 AM
Human Factors FDA Regulatory
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5 min read

ISO 10993-1:2025 Publication Is Imminent: Implications for Med Device Innovators and Manufacturers Worldwide

Picture of Lina Burman Lina Burman: Oct 22, 2025 8:23:33 AM
EU MDR FDA Regulatory Biocompatibility
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4 min read

How Proper CMS-IDE Alignment Prevents Study Delays and Budget Overruns

Picture of Marc Zimmerman Marc Zimmerman: Oct 15, 2025 10:08:54 AM
Clinical Research FDA Regulatory Commercialization
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4 min read

eQMS (Software) vs. a Scalable, Compliant, High Value QMS: Know What You're Buying

Picture of Ramona Field Ramona Field: Sep 30, 2025 6:14:08 PM
EU MDR FDA Regulatory Quality
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Clinical considerations for IDE exemption success - engineering innovators guide

5 min read

Clinical Reality Check: Core Clinical Considerations for IDE Success

Picture of Tracy Case Tracy Case: Sep 17, 2025 2:41:36 PM
Clinical Research FDA Regulatory Commercialization
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3 min read

Strategic Human Factors Testing: Unlocking Funding While Building Regulatory Compliance

Veranex: Sep 3, 2025 8:55:33 AM
Human Factors FDA Regulatory
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checklist image

6 min read

Readiness Checklist: Preparing for FDA's 2026 QMSR

Paige Sutton-Smith: Sep 2, 2025 10:24:59 AM
FDA Regulatory Quality
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4 min read

Mastering the Pre-Submission Strategy: What to Ask (and Never Ask) the FDA About Human Factors

Veranex: Jul 28, 2025 3:33:37 PM
Human Factors FDA Regulatory
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7 min read

Navigating FDA’s Latest Guidance Updates for AI-Enabled Medical Devices: A Marketing Submission Guide

Veranex: Jan 21, 2025 3:52:30 PM
FDA Regulatory Software Development AI
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