Veranex
★★★★★
3.8
/ 5
•
12 reviews
Full-Service CRO | FDA 510(k) & PMA Expert | Medtech Design, Regulatory & Commercialization
Veranex is a distinguished full-service CRO with 15 years of dedicated experience in the medtech industry. They specialize in providing end-to-end services that encompass product design, regulatory affairs, and commercialization strategies. Their core expertise lies in navigating the complex FDA regulatory landscape, particularly with a strong focus on FDA 510(k) submissions and achieving successful clearances for medical devices. Veranex also offers support for PMA submissions and serves a global clientele across the US and EU, empowering medical device companies to bring their innovations to market efficiently.
About
**Who they are**
Veranex is an Innovation Contract Research Organization (iCRO) that unites essential disciplines for medical device and diagnostic development under one roof, from concept to market launch. They leverage over 25 years of specialized knowledge across major medtech categories.
**Expertise & scope**
* Integrated capabilities for medical device & diagnostic development
* Expertise in Quality Management Systems (QMS) implementation and audit readiness
* Guidance for regulatory submissions, global market expansion, and indication expansions
* Strategic regulatory consulting for FDA, EU MDR, and IVDR requirements
* Accelerating market entry through integrated design validation and process excellence
**Reputation / proof points**
* Founded to bridge the gap between visionary concepts and market reality
* Focus on user & patient-centered innovation
* Emphasis on velocity and agile execution
Veranex is an Innovation Contract Research Organization (iCRO) that unites essential disciplines for medical device and diagnostic development under one roof, from concept to market launch. They leverage over 25 years of specialized knowledge across major medtech categories.
**Expertise & scope**
* Integrated capabilities for medical device & diagnostic development
* Expertise in Quality Management Systems (QMS) implementation and audit readiness
* Guidance for regulatory submissions, global market expansion, and indication expansions
* Strategic regulatory consulting for FDA, EU MDR, and IVDR requirements
* Accelerating market entry through integrated design validation and process excellence
**Reputation / proof points**
* Founded to bridge the gap between visionary concepts and market reality
* Focus on user & patient-centered innovation
* Emphasis on velocity and agile execution
Additional information
Veranex positions itself as an 'Innovation CRO,' distinguishing itself from traditional CROs by integrating various development disciplines to streamline the path to market. Their approach emphasizes accelerating the delivery of breakthrough devices and diagnostics. They offer outcome-driven solutions tailored to specific challenges, aiming for greater certainty and faster resolution. This integrated model is designed to prevent regulatory setbacks and accelerate market entry by aligning design validation with process excellence.
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 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”
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Provides strategic regulatory consulting for FDA, EU MDR & IVDR requirements.
Source
“Master FDA, EU MDR & IVDR Requirements with Expert Medical Device Regulatory Services”
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Focuses on preventing regulatory setbacks and accelerating market entry.
Source
“From QMS implementation to audit readiness, our quality experts prevent regulatory setbacks that delay patient access while accelerating market entry”
Certifications & Trust Signals
Buyer Snapshot
Best for
- Medical device and diagnostic companies seeking integrated development services
- Companies needing regulatory strategy and execution for FDA and EU markets
How engagement typically works
- Collaborative, outcome-driven solutions
- Agile execution to accelerate market entry
Typical deliverables
- Regulatory submission strategies
- QMS implementation and audit readiness support
- Market launch acceleration
Good to know
- Best when seeking a unified approach to device development and commercialization
HQ:
United States
Languages:
English
Claim status:
Listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment, Device Classification Support, 510(k) Strategy & Authoring, 510(k) eSTAR Preparation, Special 510(k) Support, Traditional 510(k) Support, Abbreviated 510(k) Support, 510(k) RTA Remediation / Refuse-to-Accept Fix, Predicate Research & Substantial Equivalence Strategy, De Novo Strategy & Authoring, PMA Strategy & Support, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C), Labeling Review for Submission (510(k)/De Novo/PMA), Submission Project Management (end-to-end)
Pathways Supported:
Traditional 510(k), Special 510(k), Abbreviated 510(k), De Novo, PMA, Pre-Sub / Q-Sub
Device Types Supported:
Medical device, IVD, SaMD, Combination product
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Years Experience:
20
Ex FDA:
Yes
Ex Notified Body:
Yes
Ex Big Medtech:
No
Device Panels:
Cardiovascular, Orthopedic, Neurology, General Hospital, Ophthalmology, Pulmonary, In Vitro Diagnostics (IVD), Digital Health, Software as a Medical Device (SaMD), Combination Products
Technology Types:
Software, AI/ML, Digital Health, Wearables, Implantables, Robotics, Biotechnology, Nanotechnology, 3D Printing
Engagement Models:
Project-based, Retainer, Hourly
Accepting New Clients:
Yes
Supports Estar:
Yes
Supports Labeling Review:
Yes
Provides Submission Project Management:
Yes
Num510k Submitted:
1000
Product Code Experience:
Class II Medical Devices, Class III Medical Devices, IVDs, Combination Products, Software as a Medical Device (SaMD)
Typical Lead Time Weeks:
4
Response Time Hours:
24
