Veranex

★★★★★ 3.8 / 5
• 12 reviews

Veranex is The Innovation CRO for medical devices and IVDs, providing comprehensive services including biocompatibility testing, regulatory consulting, and clinical research. Veranex offers ISO 10993 testing services and strategic guidance for medical device manufacturers navigating global regulatory requirements.

Veranex is The Innovation CRO (Contract Research Organization) for medical devices and IVDs, providing integrated services across the product development lifecycle. Veranex offers comprehensive biocompatibility testing services in accordance with ISO 10993 standards, supporting medical device manufacturers in achieving regulatory compliance for FDA, EU MDR, and international markets. The organization provides a complete range of biological safety evaluation services including cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10), irritation (ISO 10993-23), systemic toxicity (ISO 10993-11), genotoxicity (ISO 10993-3), hemocompatibility (ISO 10993-4), and pyrogenicity testing. Veranex combines testing capabilities with regulatory consulting, clinical research, and quality services to provide end-to-end support for medical device development. With expertise in both standard and specialized biocompatibility programs, Veranex helps clients develop efficient testing strategies and navigate complex regulatory pathways.

About

**Who they are**
Veranex is an Innovation CRO that unites essential disciplines for medical device and diagnostic development, accelerating the path to market. They offer integrated capabilities to solve complex challenges with deep expertise and insight.

**Expertise & scope**
* Comprehensive biological safety evaluations and toxicological risk assessments.
* Guidance from material selection through to regulatory approval.
* Services supporting medical device manufacturers navigating global regulatory requirements.
* Expertise in biocompatibility testing, regulatory consulting, and clinical research.

**Reputation / proof points**
* Over 25 years of specialized knowledge across major medtech categories.
* Focus on user and patient-centered innovation.
* Unites disciplines from sketch to market launch under one roof.

Additional information

Veranex positions itself as an 'Innovation CRO,' differentiating from traditional CROs by integrating various development disciplines. This approach aims to reduce fragmentation, costly hand-offs, and learning curves. Their model emphasizes accelerating market entry through connected and aligned services, from initial concept to evidence generation and market launch. They package outcome-driven solutions with extensive specialized knowledge to address pressing challenges with greater certainty and speed. Buyers seeking a unified development partner that accelerates innovation and market access may find Veranex's integrated approach beneficial.

Key Highlights

  • Veranex offers comprehensive biological safety evaluations and toxicological risk assessments for medical devices. Source
    “Comprehensive biological safety evaluations and toxicological risk assessments to ensure regulatory compliance and patient safety throughout your device lifecycle”
  • They provide ISO 10993 testing services and strategic guidance for medical device manufacturers. Source
    “Veranex offers ISO 10993 testing services and strategic guidance for medical device manufacturers navigating global regulatory requirements.”
  • Veranex unites essential disciplines for medical device & diagnostic development under one roof. Source
    “Veranex unites the essential disciplines for medical device & diagnostic development under one roof from sketch to evidence-generation to market launch.”

Certifications & Trust Signals

  • Veranex has over 25 years of specialized knowledge across major medtech categories. Source
    “Veranex packages outcome-driven solutions with 25+ years of specialized knowledge across major medtech categories”

Buyer Snapshot

Best for
  • Medical device and IVD manufacturers
  • Companies seeking integrated development services
  • Innovators needing to accelerate market entry
How engagement typically works
  • Outcome-driven solutions
  • Integrated capabilities
  • Agile execution
Typical deliverables
  • Biocompatibility testing reports
  • Toxicological risk assessments
  • Regulatory consulting
  • Clinical research support
Good to know
  • Best when a comprehensive, end-to-end development partner is required.
HQ: Vancouver, US
Languages: English
Claim status: Listed

Services & Capabilities

Biocompatibility Testing (ISO 10993 Program)

Industries: Medical Devices
Pricing model: Custom pricing
Iso10993 Standards Supported: ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-18
Test Types Offered: Cytotoxicity, Sensitization, Irritation, Systemic toxicity, Hemocompatibility, Pyrogenicity, Biodegradation
Is Accredited: Yes
Glp Compliant: Yes
Lead Time Band: Start in 2-4 weeks
Quote SLA: 3-5 business days
Rush Available: Yes
Sample Return Policy: Dispose
Nda Support: Yes
Minimum Project Size: <$10k
Has In House Toxicology: Yes
Contact Types Supported: Surface contact, External communicating, Implant
Duration Types Supported: Limited (< 24h), Prolonged (24h - 30d), Permanent (> 30d)
Regions Served: United States, Europe, Asia
Toxicology Capabilities: Comprehensive toxicology services including risk assessment, test strategy development, and biological safety evaluation

Additional biocompatibility_testing Details

Iso10993 Standards Supported
ISO 10993
Test Types Offered
Biocompatibility testing, Toxicological risk assessments, Biological safety evaluations
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