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, aiming to accelerate the path to market. They combine proven expertise with agile execution to bring innovations to life.
**Expertise & scope**
* Integrated capabilities from sketch to evidence generation and market launch.
* Outcome-driven solutions leveraging over 25 years of specialized knowledge in medtech.
* Quality consulting for QMS implementation, audit readiness, and integrated design validation.
* Support for accelerating market entry through process excellence.
* Biocompatibility testing and toxicological risk assessments for regulatory compliance and patient safety.
**Reputation / proof points**
* Over 25 years of specialized knowledge across major medtech categories.
Veranex is an Innovation CRO that unites essential disciplines for medical device and diagnostic development, aiming to accelerate the path to market. They combine proven expertise with agile execution to bring innovations to life.
**Expertise & scope**
* Integrated capabilities from sketch to evidence generation and market launch.
* Outcome-driven solutions leveraging over 25 years of specialized knowledge in medtech.
* Quality consulting for QMS implementation, audit readiness, and integrated design validation.
* Support for accelerating market entry through process excellence.
* Biocompatibility testing and toxicological risk assessments for regulatory compliance and patient safety.
**Reputation / proof points**
* Over 25 years of specialized knowledge across major medtech categories.
Additional information
Veranex positions itself as an "Innovation CRO," distinguishing itself from traditional CROs by integrating various development disciplines under one roof. This approach aims to reduce fragmentation, costly hand-offs, and learning curves inherent in multi-vendor development processes. Their focus is on accelerating the journey from initial concept to market launch, emphasizing velocity and certainty in bringing breakthrough devices and diagnostics to patients.
Key Highlights
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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.”
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Offers outcome-driven solutions with over 25 years of specialized medtech knowledge.
Source
“Veranex packages outcome-driven solutions with 25+ years of specialized knowledge across major medtech categories”
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Provides comprehensive biological safety evaluations and toxicological risk assessments.
Source
“Comprehensive biological safety evaluations and toxicological risk assessments to ensure regulatory compliance and patient safety”
Certifications & Trust Signals
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Founded to bridge the gap between visionary concepts and market reality.
Source
“Veranex was founded to bridge the gap between visionary concepts and market reality”
Buyer Snapshot
Best for
- Medical device and diagnostic companies seeking integrated development support.
- Organizations needing to accelerate time-to-market for innovative products.
- Companies requiring expertise in quality consulting and regulatory compliance.
How engagement typically works
- Collaborative partnership from concept to launch.
- Leveraging deep medtech expertise for tailored solutions.
- Agile execution to drive innovation velocity.
Typical deliverables
- Integrated medical device development services.
- Quality management system (QMS) implementation.
- Design validation and process excellence.
- Biocompatibility and toxicological risk assessments.
- Regulatory compliance support.
Good to know
- Best when seeking a unified development partner to streamline processes.
HQ:
Vancouver, US
Languages:
English
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, USP <87>, USP <88>
Test Types Offered:
Cytotoxicity, Sensitization, Irritation, Systemic toxicity, Genotoxicity, Implantation, Hemocompatibility, Pyrogenicity
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:
Both options
Nda Support:
No
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
