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 combine over 25 years of specialized knowledge across major medtech categories to deliver integrated capabilities.
**Expertise & scope**
* Comprehensive biological safety evaluations and toxicological risk assessments.
* Strategic guidance for medical device manufacturers navigating global regulatory requirements.
* ISO 10993 testing services.
* Regulatory consulting.
* Clinical research.
* Quality consulting, including QMS implementation and audit readiness.
* Integrated design validation and process excellence.
**Reputation / proof points**
* Over 25 years of specialized knowledge.
* Unites essential disciplines under one roof from sketch to market launch.
Veranex is an Innovation CRO that unites essential disciplines for medical device and diagnostic development, accelerating the path to market. They combine over 25 years of specialized knowledge across major medtech categories to deliver integrated capabilities.
**Expertise & scope**
* Comprehensive biological safety evaluations and toxicological risk assessments.
* Strategic guidance for medical device manufacturers navigating global regulatory requirements.
* ISO 10993 testing services.
* Regulatory consulting.
* Clinical research.
* Quality consulting, including QMS implementation and audit readiness.
* Integrated design validation and process excellence.
**Reputation / proof points**
* Over 25 years of specialized knowledge.
* Unites essential disciplines under one roof from sketch to market launch.
Additional information
Veranex positions itself as an 'Innovation CRO,' aiming to accelerate the market entry of medical devices and diagnostics by integrating various development disciplines. Their approach focuses on bridging visionary concepts with market reality through agile execution and deep expertise. This integrated model is designed to reduce the fragmentation often seen with traditional CROs, leading to faster development cycles and greater certainty in achieving market access.
Key Highlights
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Veranex offers comprehensive biological safety evaluations and toxicological risk assessments.
Source
“Comprehensive biological safety evaluations and toxicological risk assessments to ensure regulatory compliance and patient safety throughout your device lifecycle”
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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.”
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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.”
Certifications & Trust Signals
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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 seeking integrated development services.
- Companies needing to navigate complex global regulatory requirements.
How engagement typically works
- Integrated service delivery from concept to market launch.
- Outcome-driven solutions leveraging deep expertise.
Typical deliverables
- Biocompatibility testing reports.
- Biological risk assessments.
- Toxicological risk assessments.
- Regulatory consulting.
- QMS implementation.
Good to know
- Best when a holistic, end-to-end development partner is desired.
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, Biological safety evaluations, Toxicological risk assessments
