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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.

 

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.

 

Accelerating Diagnostic Innovation: Expert IVD Consulting from Idea to Market

Transform your diagnostic vision into market reality with our comprehensive IVD consulting expertise spanning product development, regulatory strategy, clinical validation, and commercial success across global markets.

The IVD Consulting Partner That Delivers Results Across Every Innovation Stage

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2500
+

Projects Completed

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700
+

Patents Filed

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35
+

Years of Experience

Veranex’s IVD Consulting Experience

From point-of-care innovation to complex laboratory systems, our multidisciplinary knowledge spans the complete diagnostic technology spectrum.

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Point-of-Care Testing Devices

Diverse commercial tests spanning low to high regulatory risk

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Laboratory-Developed Tests (LDTs)

Lab-made tests with varied risk and evolving regulation

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Companion Diagnostics (CDx)

High-risk tests directly link to specific drug therapies

Comprehensive IVD Consulting Services for Diagnostic Excellence

Your Complete Partner from Laboratory Concept to Global Market Success 


Veranex's IVD consulting services provide end-to-end support for diagnostic innovation, from initial product design and engineering through regulatory approval and commercial launch. Our multidisciplinary team combines deep product development expertise with scientific rigor and commercial insight, delivering integrated solutions that transform technical innovation into market-ready diagnostic products while addressing complex regulatory pathways and evolving reimbursement landscapes.

Design and Engineering to Control Risk from Concept Through Manufacturing

We specialize in the design, engineering, and manufacturing of diagnostic technologies across diverse platforms. Our team brings extensive experience with point-of-care testing devices, centralized laboratory equipment, cartridge development, and early-stage technology development using our proprietary pre-built technology stack.

Our product design approach integrates regulatory considerations from the earliest concept stages, ensuring your diagnostic innovation meets both technical performance requirements and compliance standards. We provide:

  • Rapid prototyping and proof-of-concept development
  • Complete multidisciplinary design spanning industrial design, mechanics, electronics, software, firmware, and optical systems
  • Risk management integration throughout the design process
  • Design controls implementation aligned with FDA and IVDR requirements
  • Manufacturing readiness support and scale-up guidance

US and EU Regulatory Experience to Optimize Your IVD Submission

With decades of combined experience navigating both US FDA and EU regulatory pathways for diagnostic technologies, our team understands the nuances of IVD classification, risk stratification, and the evolving regulatory landscape that shapes market access. Our strategic approach ensures your diagnostic innovation meets regulatory requirements while optimizing time-to-market and commercial viability.

US FDA

  • Strategic Pathway Selection & Optimization
  • Submission Development & Review Management
  • Clinical & Testing Strategy Optimization
  • Post-approval Compliance & Lifecycle Management

EU IVDR

  • CE-Mark Strategy Optimization
  • Technical Documentation & QMS Excellence
  • Performance Evaluation Expertise
  • Notified Body & Certification Support

IVD Clinical Study Support

Our clinical research experts design and manage IVD clinical studies that generate robust evidence for regulatory approval and market access. We understand the unique requirements of diagnostic clinical investigations, from analytical performance validation to real-world clinical utility demonstration.

Our IVD clinical services include:

  • Clinical study design optimized for diagnostic technologies
  • Analytical and clinical performance study protocols
  • Site selection and management for diagnostic-specific endpoints
  • Statistical analysis and reporting tailored to regulatory requirements
  • Post-market clinical follow-up and real-world evidence generation
  • Multi-site coordination for global regulatory submissions

Comprehensive Commercialization IVD Strategy Services 

We partner with diagnostic innovators to navigate complex reimbursement landscapes and develop viable go-to-market strategies. Our established relationships with payers and providers provide unique insights into coverage decisions, pricing considerations, and market access requirements.

Our commercialization strategy services encompass:

  • Health economics and outcomes research (HEOR) for diagnostic value demonstration
  • Payer engagement and coverage strategy development
  • Clinical utility evidence generation and value proposition refinement
  • Market access pathway optimization for novel diagnostic technologies
  • Go-to-market strategy alignment with reimbursement realities
  • Commercial team training and market preparation support

Meet the Team

Meet the IVD Consulting Experts Driving Your Innovation Forward

Proven Leaders with Deep Diagnostic Industry Experience

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Lenny Silverman

Principal Mechanical Engineer
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Silvia Anghel, Ph.D. 

Sr Director, Quality and Regulatory Affairs
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Joseph Ferrara 

Chief Strategy Officer

Case Studies

How our IVD Consultants Deliver Diagnostic Excellence

Proven Results Across Diagnostic Technologies and Global Markets

Transform Your Vision into Market Reality with Expert IVD Consulting

Partner with the team that understands both the science and business of diagnostic success.