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
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.
Additional information
### **Additional information**
- **Type:** firm
- **Company:** Veranex
- **Years of experience:** 15
- **Regions served:** US, EU
- **Client types:** startup, sme, large_medtech
- **Location:** United States
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** Veranex distinguishes itself as a full-service CRO with 15 years of experience, offering a unique end-to-end medtech service model encompassing design, regulatory, and commercialization. Their core strength lies in FDA 510(k) regulatory consulting, specializing in successful clearances for Class I and Class II medical devices, including the nuanced area of Software as a Medical Device (SaMD). This comprehensive offering, coupled with their experience in PMA submissions and a global service footprint (US, EU, Global), positions them as a strategic partner capable of guiding clients through complex regulatory landscapes from concept to market.
- **Unique value:** Veranex's key differentiator is its full-service CRO model, providing integrated end-to-end medtech solutions from design to commercialization, with deep specialization in FDA 510(k) regulatory consulting for Class I, Class II, and SaMD devices. This holistic approach ensures regulatory strategy is embedded from the outset, streamlining the entire product development and market entry process.
- **Ideal projects:** The ideal client for Veranex is a medical device company, particularly those developing Class I or Class II devices, with a specific need for expertise in Software as a Medical Device (SaMD), seeking comprehensive support beyond just regulatory submissions. They are best suited for projects requiring integrated, end-to-end services, from initial product design and development through regulatory strategy (510(k) or PMA) to commercialization, across US, EU, or global markets. Companies looking for a partner to not only prepare and submit FDA 510(k)s but also embed regulatory considerations throughout their entire product lifecycle will find Veranex an excellent fit.
- **Confidence score:** 70/100
- **Last analyzed:** Sun Dec 14 2025 01:15:55 GMT-0500 (Eastern Standard Time)
### **Qualifications & scope**
- **Submission types:** 510k-traditional, pma, international
- **Device classes:** class-i, class-ii
- **Specialties:** software-samd, regulatory strategy, risk management
- **Regulatory pathways:** 510k, pma
- **Type:** firm
- **Company:** Veranex
- **Years of experience:** 15
- **Regions served:** US, EU
- **Client types:** startup, sme, large_medtech
- **Location:** United States
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** Veranex distinguishes itself as a full-service CRO with 15 years of experience, offering a unique end-to-end medtech service model encompassing design, regulatory, and commercialization. Their core strength lies in FDA 510(k) regulatory consulting, specializing in successful clearances for Class I and Class II medical devices, including the nuanced area of Software as a Medical Device (SaMD). This comprehensive offering, coupled with their experience in PMA submissions and a global service footprint (US, EU, Global), positions them as a strategic partner capable of guiding clients through complex regulatory landscapes from concept to market.
- **Unique value:** Veranex's key differentiator is its full-service CRO model, providing integrated end-to-end medtech solutions from design to commercialization, with deep specialization in FDA 510(k) regulatory consulting for Class I, Class II, and SaMD devices. This holistic approach ensures regulatory strategy is embedded from the outset, streamlining the entire product development and market entry process.
- **Ideal projects:** The ideal client for Veranex is a medical device company, particularly those developing Class I or Class II devices, with a specific need for expertise in Software as a Medical Device (SaMD), seeking comprehensive support beyond just regulatory submissions. They are best suited for projects requiring integrated, end-to-end services, from initial product design and development through regulatory strategy (510(k) or PMA) to commercialization, across US, EU, or global markets. Companies looking for a partner to not only prepare and submit FDA 510(k)s but also embed regulatory considerations throughout their entire product lifecycle will find Veranex an excellent fit.
- **Confidence score:** 70/100
- **Last analyzed:** Sun Dec 14 2025 01:15:55 GMT-0500 (Eastern Standard Time)
### **Qualifications & scope**
- **Submission types:** 510k-traditional, pma, international
- **Device classes:** class-i, class-ii
- **Specialties:** software-samd, regulatory strategy, risk management
- **Regulatory pathways:** 510k, pma
Key Highlights
- Veranex distinguishes itself as a full-service CRO with 15 years of experience, offering a unique end-to-end medtech service model encompassing design, regulatory, and commercialization. Their core strength lies in FDA 510(k) regulatory consulting, specializing in successful clearances for Class I and Class II medical devices, including the nuanced area of Software as a Medical Device (SaMD). This comprehensive offering, coupled with their experience in PMA submissions and a global service footp
- Veranex's key differentiator is its full-service CRO model, providing integrated end-to-end medtech solutions from design to commercialization, with deep specialization in FDA 510(k) regulatory consulting for Class I, Class II, and SaMD devices. This holistic approach ensures regulatory strategy is embedded from the outset, streamlining the entire product development and market entry process.
Certifications & Trust Signals
- 15 years experience
Buyer Snapshot
Best for
- The ideal client for Veranex is a medical device company, particularly those developing Class I or Class II devices, with a specific need for expertise in Software as a Medical Device (SaMD), seeking comprehensive support beyond just regulatory submissions. They are best suited for projects requiring integrated, end-to-end services, from initial product design and development through regulatory st
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
