Maven ProfServ
★★★★★
4.8
/ 5
•
91 reviews
FDA 510(k) Regulatory Consulting for Global Medical Device Manufacturers - IVD Specialist
Maven ProfServ is a dedicated consulting firm specializing in FDA 510(k) regulatory support for global medical device manufacturers. With 12 years of experience, they offer expert assistance for traditional 510(k) submissions for Class I and Class II medical devices, with a strong focus on In Vitro Diagnostic (IVD) products. Maven ProfServ is committed to helping medical device companies successfully navigate FDA regulatory pathways and achieve timely clearances.
About
Maven ProfServ is a dedicated consulting firm specializing in FDA 510(k) regulatory support for global medical device manufacturers. With 12 years of experience, they offer expert assistance for traditional 510(k) submissions for Class I and Class II medical devices, with a strong focus on In Vitro Diagnostic (IVD) products. Maven ProfServ is committed to helping medical device companies successfully navigate FDA regulatory pathways and achieve timely clearances.
Additional information
### **Cruxi analysis**
- **Strength summary:** Maven ProfServ, a consulting firm with 12 years of experience, offers highly specialized FDA 510(k) regulatory consulting, particularly for global manufacturers targeting the US market. Their expertise is sharply focused on traditional 510(k) submissions for Class I and Class II medical devices, with a distinct specialization in In Vitro Diagnostic (IVD) products. This deep niche focus, combined with their experience, positions them as a reliable partner for companies seeking to efficiently navigate the complexities of FDA clearance specifically within these device categories. They are adept at helping medical device companies achieve successful 510(k) clearances.
- **Unique value:** Maven ProfServ's key differentiator is their highly specialized and globally-focused expertise in traditional 510(k) submissions for Class I and Class II medical devices, particularly their noted strength in In Vitro Diagnostics (IVDs). This focused niche allows them to provide deep, targeted support for manufacturers navigating this specific FDA pathway.
- **Ideal projects:** The ideal client for Maven ProfServ is a global medical device manufacturer, or a US-based company, developing Class I or Class II devices, especially those in the In Vitro Diagnostic (IVD) space, who require expert guidance for their traditional 510(k) submission. They are best suited for projects where comprehensive support is needed to navigate the FDA regulatory pathway, from initial strategy to successful clearance, offered under a fixed-project pricing structure. Companies seeking a dedicated partner with a proven track record in 510(k) for these specific device types and a global client service approach would find Maven ProfServ to be an excellent fit.
- **Last analyzed:** Sun Dec 14 2025 01:14:46 GMT-0500 (Eastern Standard Time)
---
### **Qualifications & scope**
- **Submission types:** 510k-traditional
- **Device classes:** class-i, class-ii
- **Specialties:** ivd, regulatory strategy
- **Device panels:** ivd
- **Regulatory pathways:** 510k
---
### **Additional information**
- Type: firm
- Company: Maven ProfServ
- Years of experience: 12
- 510(k)s submitted (self-reported): 10
- Location: United States
- Availability: available_now
- **Strength summary:** Maven ProfServ, a consulting firm with 12 years of experience, offers highly specialized FDA 510(k) regulatory consulting, particularly for global manufacturers targeting the US market. Their expertise is sharply focused on traditional 510(k) submissions for Class I and Class II medical devices, with a distinct specialization in In Vitro Diagnostic (IVD) products. This deep niche focus, combined with their experience, positions them as a reliable partner for companies seeking to efficiently navigate the complexities of FDA clearance specifically within these device categories. They are adept at helping medical device companies achieve successful 510(k) clearances.
- **Unique value:** Maven ProfServ's key differentiator is their highly specialized and globally-focused expertise in traditional 510(k) submissions for Class I and Class II medical devices, particularly their noted strength in In Vitro Diagnostics (IVDs). This focused niche allows them to provide deep, targeted support for manufacturers navigating this specific FDA pathway.
- **Ideal projects:** The ideal client for Maven ProfServ is a global medical device manufacturer, or a US-based company, developing Class I or Class II devices, especially those in the In Vitro Diagnostic (IVD) space, who require expert guidance for their traditional 510(k) submission. They are best suited for projects where comprehensive support is needed to navigate the FDA regulatory pathway, from initial strategy to successful clearance, offered under a fixed-project pricing structure. Companies seeking a dedicated partner with a proven track record in 510(k) for these specific device types and a global client service approach would find Maven ProfServ to be an excellent fit.
- **Last analyzed:** Sun Dec 14 2025 01:14:46 GMT-0500 (Eastern Standard Time)
---
### **Qualifications & scope**
- **Submission types:** 510k-traditional
- **Device classes:** class-i, class-ii
- **Specialties:** ivd, regulatory strategy
- **Device panels:** ivd
- **Regulatory pathways:** 510k
---
### **Additional information**
- Type: firm
- Company: Maven ProfServ
- Years of experience: 12
- 510(k)s submitted (self-reported): 10
- Location: United States
- Availability: available_now
HQ:
United States
Languages:
English
Status:
claimed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment, Device Classification Support, 510(k) Strategy & Authoring, Predicate Research & Substantial Equivalence Strategy
Pathways Supported:
Traditional 510(k)
Device Types Supported:
IVD, Medical device
Supports Predicate Research:
Yes
Years Experience:
12
Num510k Submitted:
10
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Device Panels:
ivd
Engagement Models:
fixed_fee
Accepting New Clients:
No
