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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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Driving Innovation Forward with Strategic Medical Device Quality Consulting 

From QMS implementation to audit readiness, our quality experts prevent regulatory setbacks that delay patient access while accelerating market entry through integrated design validation and process excellence.

Next-Generation Quality Assurance for Medical Devices: Swift Approvals, Life-Changing Patient Outcomes


Medical device quality consulting requires strategic integration of quality systems with regulatory compliance and overall product development processes, to prevent costly market access delays and recalls.

This is the Veranex Solution

As an Innovation CRO (iCRO), we synchronize quality management with upstream engineering and downstream manufacturing, ensuring your quality framework scales seamlessly from prototype through commercial production.

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Strategic Integration

Quality systems synchronized with product development, validation protocols, and regulatory pathways.

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Early Implementation

Robust quality frameworks established before design verification to capture risk effectively.

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Lean Scalability

Systems that support rapid iteration while maintaining manufacturing scale-up readiness.

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Comprehensive Coverage

ISO 13485 certification, design validation, process validation, and FDA inspection preparation.

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Quality Consulting

Our Services

Design and Manufacturing Quality Services

Design and Manufacturing Quality Services

V&V-ready design controls with complete traceability satisfying FDA, EU MDR, and ISO 13485 requirements. 

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QMS Consulting 

QMS Consulting 

ISO 13485-compliant quality management systems that integrate seamlessly with product development, including rapid innovation cycles.

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Process Validation 

Process Validation 

Comprehensive IQ • OQ • PQ validation consulting. For any manufacturing, sterilization, packaging, and cleaning needs to prevent recalls and regulatory setbacks.

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Audit Readiness

Audit Readiness

FDA mock inspections, ISO 13485 gap assessments, and MDSAP preparation with proven 90-day readiness roadmaps.

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What Clients Say

"Our Veranex partners demonstrate exceptional flexibility, professionalism, and quality of service delivery, while most importantly bringing outstanding technical and human skills to every engagement."

COO, mid-size medtech company, Switzerland
 

What Clients Say

"Veranex has very well educated and knowledgeable staff who are very attentive to the details of the information provided along with the information they need to gather."

Regulatory Affairs Manager, large dental product manufacturer, US

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Meet the Team

Your Veranex Quality Consulting Partners 
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Naghmeh Nouri 

Executive Director, Quality Engineering
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Cédric Razaname

Director, Quality and Regulatory Affairs
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Stephany Esa, MSc.

Director, Design Assurance Engineering

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.

Ready to Build Quality Excellence Into Your Medical Device?

Let’s work together on building and implementing quality systems that scale with your growth.

Contact Our Specialists