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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.

 

Design Medical Device Clinical Trials That Fast-Track Regulatory Success

Our proven protocol development accelerates study timelines while ensuring global compliance—delivering patient-centric trial designs that regulatory authorities trust and investigators execute flawlessly.

Evidence-Backed Clinical Trial Protocol Development Built for Regulatory Success 

Compliance strategies across FDA, CE marking, worldwide jurisdictions.

 

Global Regulatory Intelligence 

Study designs that minimize burden while accelerating life-changing technology access.

 

Patient-Centric Architecture

Leverage insights for feasible protocols, reduced time to market globally.

 

Real-World Data Integration

Trial Design

Comprehensive Medical Device Clinical Trial Design Across Every Development Phase

Medical device clinical trial design demands precision at every protocol decision point. Our methodology combines regulatory intelligence with patient-centric study architecture, ensuring your clinical investigation meets global regulatory requirements while accelerating patient access to life-changing technologies. 

Whether you have a medical device, IVD, or software solution, we design studies that generate compelling evidence packages and withstand regulatory scrutiny across all major jurisdictions.

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Patient-Centric Protocols that Investigators can Execute Efficiently

Our comprehensive clinical trial planning services cover every aspect of protocol development, built on ISO 14155 and ISO 20916 standards to ensure worldwide acceptance of study results:

  • Identification of clinical endpoints pertinent to safety and/or performance of the device
  • Definition of clinical study type (e.g., significant vs. non-significant risk, superiority vs. non-inferiority/equivalence)
  • Sample size considerations
  • Statistical Analysis Plan (SAP) establishment
  • Development of the Clinical Investigation Plan (CIP) in compliance with Good Clinical Practice (GCP)
  • Assembly of Investigator's Brochure (IB)
  • Selection and qualification of clinical study sites
  • Structure of electronic Case Report Form (eCRF) architecture
  • Compilation of other relevant components of the Trial Master File (TMF)

Core Planning Capabilities Applied Across Different Study Types

Feasibility Studies 

Feasibility Studies 

Trail-blazing study designs that validate device safety and performance early, incorporating adaptive methodologies to accelerate proof-of-concept while minimizing patient exposure and study costs.

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Pivotal Trials

Pivotal Trials 

Evidence-based pivotal study protocols engineered for regulatory success, featuring patient-centric endpoints and streamlined data collection that supports compelling 510(k)/ or PMA submissions and/or CE Marking.

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Post-Market Surveillance

Post-Market Surveillance

Strategic post-market surveillance study designs that satisfy regulatory requirements while generating safety and performance data for ongoing compliance and continuous improvement.

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IVD Clinical Studies

IVD Clinical Studies

Specialized in vitro diagnostic clinical evaluation protocols that meet FDA and CE marking requirements, optimizing study populations and statistical approaches for device-specific performance validation.

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Real-World Evidence

Real-World Evidence

Patient-centric real-world evidence study designs that capture meaningful clinical outcomes in routine care settings, supporting regulatory submissions and payer value demonstrations.

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Meet the Team

Clinical Design Experts Who Deliver Regulatory Wins

delphine-huser

Delphine Huser, PhD 

Director, Clinical Affairs
tracey-case

Tracy Case

Director, Clinical Affairs
Anna-Rydberg

Anna Rydberg

Sr Clinical Study Manager

Case Studies

Medical Device Clinical Trial Design Success Stories, From Protocol to Approval

Real-World Impact Through Evidence-Based Study Architecture

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Related Services at Veranex

Clinical Trial Management 

Clinical Trial Management 

End-to-end clinical trial execution that transforms your evidence-backed protocols into regulatory-grade data packages.

Learn more

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Real World Evidence

Real World Evidence

Patient-centric real-world evidence strategies that strengthen your regulatory submissions and unlock reimbursement pathways through compelling clinical outcomes data.

Learn more

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EU MDR Consulting 

EU MDR Consulting 

Smart compliance strategies that accelerate CE marking timelines while ensuring your clinical evidence package meets notified body expectations.

Learn more

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FDA Consulting  

FDA Consulting  

Evidence-based FDA submission strategies that fast-track 510(k) and PMA approvals through regulatory intelligence and submission optimization expertise.

Learn more

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Accelerate Your Medical Device Clinical Trial Design Timeline

Transform clinical development into regulatory-grade evidence packages.