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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.

Explore our Services

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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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Comprehensive Medical Writing Services for Medical Devices & IVDs 

From essential regulatory documentation to professional scientific communication, our team of PhD scientists and regulatory experts delivers precise, compliant medical writing that accelerates your device's path to market.

Proof-Driven Medical Writing That Regulators Trust 


Regulators read thousands of pages each month; clarity and evidence density decide who passes the first review cycle. With a proven track-record of successful scientific and medical writing, we interpret statistics, establish the state‑of‑the‑art and clinical strategies based on available literature, and seamlessly integrate regulatory requirements into every line. The outcome: dossiers that meet the expectations of FDA reviewers, EU notified bodies, and global authorities, minimizing the need for repeated rounds of clarification—saving both time and budget. 
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90
%

PhD scientists on team

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170
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Peer‑reviewed publications  

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200
+

Clinical / Performance Evaluations since 2020

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Transform Complex Requirements into Clear, Compliant Documentation

Our integrated medical writing team creates authoritative narratives that anticipate reviewer questions by aligning clinical, regulatory, and statistical requirements. From Clinical Study Protocols and Clinical Evaluations to Performance Evaluations and post market reports, we calibrate depth and format to each regulatory landscape, maximizing the value of your evidence from concept through commercialization across global markets.

Key Benefits:
  • Faster regulatory submissions with compliant documentation
  • Reduced review cycles through strategic positioning
  • Global regulatory expertise across all device classes
  • Scientific rigor that withstands regulatory scrutiny

Medical Writing Services Across Your Device Lifecycle

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Turn scattered data into decisive dossiers. Our writers craft tailored clinical strategies and translate evidence into regulator-compliant Clinical and Performance Evaluations, seamlessly aligned with risk documentation and IFUs—clearing gates faster, with fewer questions.

For Medical Devices

  • Clinical Evaluations (CEP/CER)
  • Summary of Safety and Clinical Performance (SSCP)
  • PMCF Plan and Report

For IVDs

  • Performance Evaluations (PEP/PER)
  • Summary of Safety and Performance (SSP)

Explore Regulatory Services

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Design trials that anticipate every regulator. By aligning study objective, endpoints, and evidence targets up-front with device-specific clinical strategies — we ensure protocols launch fast and final reports (CIR, PSR, or IDE Final Report) pass first review without costly rewrites.

  • Global-ready protocols: MDR & ISO 14155, IVDR & ISO 20916 and FDA IDE

  • Benchmark & predicate mapping: pinpoints optimal clinical strategy by identifying the right performance & safety parameters 

  • Acceptance criteria set early: clear success thresholds regulatory authorities expect

  • Lean, stats-powered design: right size, right power

  • Pre-built CIR / PSR / IDE shells: rapid close-out

  • Purpose-built post-market evidence strategies: paving the way to compliant and efficient PMCF

Explore Trial Design

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Comprehensive review of the relevant literature, in conjunction with meticulous vigilance searches, provide critical insights into the product's efficacy and associated risks, arming your team with the intel regulators and payers expect. Our team delivers methodological literature searches, conducted in accordance to the expectations of regulatory bodies (MEDDEV 2.7/1 rev 4 guideline).

  • SOTA assessment:

    • Clinical Evaluation / Performance Evaluation

    • Clinical strategy: Identification of efficacy and safety endpoints for clinical investigation design

    • Support for Health Economic Model and Reimbursement 

  • Vigilance data searches as input to Post-Market Surveillance (PMS)

  • Verification & Validation (V&V): identification of state-of-the-art testing, endpoints and acceptance criteria

  • Risk Management: Identification of potential hazards / hazardous situations / harms

 

Health Economic Model & Reimbursement

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Let the numbers speak with authority. Advanced stats, meta-analyses, and dynamic visuals convert complex datasets into actionable proof reviewers trust.

  • Hypothesis and sample size calculation
  • Data analysis and visualization for Clinical Evaluation, Clinical Investigation, Performance Studies, Preclinical studies, etc.
  • Meta-analysis

Explore Biostatistics Services

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Share the story behind the science. Engaging manuscripts, white papers, and posters translate device innovation into patient impact and market momentum.

Our scientific writing services help you communicate your device's value to the broader medical and scientific community through:

  • Scientific Publications
  • White papers
  • Posters

Case Studies

Medical Writing for Medical Devices: Client Achievements

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Clinical Evaluation for Dialysis System 

 

Situation

A medical device company required clinical evaluations for their dialysis system consisting of five components: the main dialysis machine and four disposable sets, each designed for different clinical indications.

Successes

Over a two-year partnership, Veranex collaborated cross-functionally with teams from multiple departments to develop and align on a unified global clinical strategy. The clinical evaluations are currently under review by a renowned notified body, with minimal non-conformities identified in the first round of revisions. The client expressed high satisfaction with the project outcome and valued the flexibility provided throughout the collaboration.

Services by Veranex

Veranex provided comprehensive clinical and regulatory support across multiple areas:

  • Clinical Documentation: Prepared detailed Clinical Evaluation Plans and Clinical Evaluation Reports for all five system components.
  • Strategic Clinical Planning: Defined the overall clinical strategy by identifying relevant safety and performance parameters, establishing acceptance criteria, supporting equivalence demonstrations with predecessor devices, and preparing justifications for waiving pre-market clinical investigations.
  • Literature Analysis: Conducted comprehensive literature reviews to establish the current state of the art, which the client actively utilized to inform their risk analysis and Instructions for Use (IFU) development.

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Related Services at Veranex

Regulatory Consulting 

 

Navigate complex global regulations with confidence through our comprehensive regulatory strategy and submission support services.

Regulatory Consulting

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Clinical Trial Design

 

Design robust clinical studies that generate the evidence you need for regulatory approval and commercial success. 

Trial Design

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Clinical Data Management

 

Ensure data integrity and regulatory compliance with our expert clinical data management and statistical analysis services.

Clinical Data Management

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Commercialization

 

Bridge the gap between regulatory approval and market success with our commercial strategy services.

Commercialization

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Accelerate Submission with Device-Focused Medical Writing

Discover how our medical writing services de-risk your next milestone and free your engineers and research professionals to keep innovating.

Research with Veranex