NAMSA
★★★★★
3.5
/ 5
•
16 reviews
NAMSA: FDA 510(k) Regulatory Consulting Expert | 15 Years Experience | Global Support
NAMSA is a leading full-service CRO with 15 years of experience, specializing in FDA 510(k) regulatory consulting for medical device companies. Their dedicated team expertly guides clients through complex FDA regulatory pathways, ensuring successful 510(k) clearances for Class I, Class II, and Class III devices. With extensive experience in IVD and Radiology, NAMSA offers comprehensive support globally, serving clients in the US, EU, and worldwide.
About
NAMSA is a leading full-service CRO with 15 years of experience, specializing in FDA 510(k) regulatory consulting for medical device companies. Their dedicated team expertly guides clients through complex FDA regulatory pathways, ensuring successful 510(k) clearances for Class I, Class II, and Class III devices. With extensive experience in IVD and Radiology, NAMSA offers comprehensive support globally, serving clients in the US, EU, and worldwide.
Additional information
### **Additional information**
- **Type:** firm
- **Company:** NAMSA
- **Years of experience:** 15
- **Regions served:** US, EU
- **Location:** United States
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** NAMSA distinguishes itself as a large, full-service CRO with 15 years of experience, specifically specializing in FDA 510(k) regulatory consulting. Their dedicated 510(k) regulatory consulting team provides comprehensive support for medical device companies, guiding them through complex pathways to achieve successful clearances. With expertise spanning Class I, Class II, and Class III devices, and specialized knowledge in IVD and Radiology, NAMSA offers a robust solution for diverse product types. Their global reach, serving clients in the US, EU, and globally, further enhances their capacity to handle international regulatory challenges and provide integrated solutions.
- **Unique value:** NAMSA's key differentiator is its unique position as a large, full-service CRO offering a dedicated and deeply experienced FDA 510(k) regulatory consulting team, providing integrated, end-to-end support for medical device companies across all device classes and global regions.
- **Ideal projects:** The ideal client for NAMSA is a medical device company, regardless of size, seeking efficient and successful FDA 510(k) clearances for Class I, Class II, or Class III devices. Projects involving IVD or Radiology devices are particularly well-suited given NAMSA's stated specialties. Clients who value a full-service partner capable of integrating regulatory consulting within a broader CRO framework, and those operating or expanding into global markets (US, EU, Global), would find NAMSA's extensive capabilities and fixed-project pricing structure highly beneficial for their regulatory needs.
- **Confidence score:** 70/100
- **Last analyzed:** Sun Dec 14 2025 01:14:31 GMT-0500 (Eastern Standard Time)
### **Qualifications & scope**
- **Submission types:** 510k-traditional, clinical-trials
- **Device classes:** class-i, class-ii, class-iii
- **Specialties:** ivd, radiology, regulatory strategy, clinical trials
- **Device panels:** ivd, radiology
- **Regulatory pathways:** 510k
- **Type:** firm
- **Company:** NAMSA
- **Years of experience:** 15
- **Regions served:** US, EU
- **Location:** United States
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** NAMSA distinguishes itself as a large, full-service CRO with 15 years of experience, specifically specializing in FDA 510(k) regulatory consulting. Their dedicated 510(k) regulatory consulting team provides comprehensive support for medical device companies, guiding them through complex pathways to achieve successful clearances. With expertise spanning Class I, Class II, and Class III devices, and specialized knowledge in IVD and Radiology, NAMSA offers a robust solution for diverse product types. Their global reach, serving clients in the US, EU, and globally, further enhances their capacity to handle international regulatory challenges and provide integrated solutions.
- **Unique value:** NAMSA's key differentiator is its unique position as a large, full-service CRO offering a dedicated and deeply experienced FDA 510(k) regulatory consulting team, providing integrated, end-to-end support for medical device companies across all device classes and global regions.
- **Ideal projects:** The ideal client for NAMSA is a medical device company, regardless of size, seeking efficient and successful FDA 510(k) clearances for Class I, Class II, or Class III devices. Projects involving IVD or Radiology devices are particularly well-suited given NAMSA's stated specialties. Clients who value a full-service partner capable of integrating regulatory consulting within a broader CRO framework, and those operating or expanding into global markets (US, EU, Global), would find NAMSA's extensive capabilities and fixed-project pricing structure highly beneficial for their regulatory needs.
- **Confidence score:** 70/100
- **Last analyzed:** Sun Dec 14 2025 01:14:31 GMT-0500 (Eastern Standard Time)
### **Qualifications & scope**
- **Submission types:** 510k-traditional, clinical-trials
- **Device classes:** class-i, class-ii, class-iii
- **Specialties:** ivd, radiology, regulatory strategy, clinical trials
- **Device panels:** ivd, radiology
- **Regulatory pathways:** 510k
Key Highlights
- NAMSA distinguishes itself as a large, full-service CRO with 15 years of experience, specifically specializing in FDA 510(k) regulatory consulting. Their dedicated 510(k) regulatory consulting team provides comprehensive support for medical device companies, guiding them through complex pathways to achieve successful clearances. With expertise spanning Class I, Class II, and Class III devices, and specialized knowledge in IVD and Radiology, NAMSA offers a robust solution for diverse product type
- NAMSA's key differentiator is its unique position as a large, full-service CRO offering a dedicated and deeply experienced FDA 510(k) regulatory consulting team, providing integrated, end-to-end support for medical device companies across all device classes and global regions.
Certifications & Trust Signals
- 15 years experience
Buyer Snapshot
Best for
- The ideal client for NAMSA is a medical device company, regardless of size, seeking efficient and successful FDA 510(k) clearances for Class I, Class II, or Class III devices. Projects involving IVD or Radiology devices are particularly well-suited given NAMSA's stated specialties. Clients who value a full-service partner capable of integrating regulatory consulting within a broader CRO framework,
HQ:
United States
Languages:
English
Status:
listed
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:
15
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Device Panels:
ivd, radiology
Engagement Models:
fixed_fee
Accepting New Clients:
No
