Intertek
★★★★★
2.7
/ 5
•
27 reviews
Expert FDA 510(k) Regulatory Consulting Firm | Global Testing & Training
Intertek is a distinguished full-service CRO and global testing organization with extensive expertise in FDA 510(k) regulatory consulting. They specialize in providing comprehensive 510(k) consulting and training services, empowering medical device companies to successfully navigate complex FDA regulatory pathways and achieve timely clearances. Intertek serves clients across the US, EU, and globally, offering dedicated support for regulatory success.
About
Intertek is a distinguished full-service CRO and global testing organization with extensive expertise in FDA 510(k) regulatory consulting. They specialize in providing comprehensive 510(k) consulting and training services, empowering medical device companies to successfully navigate complex FDA regulatory pathways and achieve timely clearances. Intertek serves clients across the US, EU, and globally, offering dedicated support for regulatory success.
Additional information
### **Additional information**
- **Type:** firm
- **Company:** Intertek
- **Years of experience:** 15
- **Regions served:** US, EU
- **Location:** United States
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** Intertek offers FDA 510(k) consulting services, focusing on efficient navigation of the submission process. Their expertise lies in helping companies achieve market success through FDA clearance.
- **Unique value:** Intertek provides efficient FDA 510(k) submission support to help medical device companies achieve market success.
- **Ideal projects:** The ideal client is a medical device company seeking FDA 510(k) clearance and looking for guidance through the submission process. This includes companies needing assistance with regulatory strategy and efficient market access.
- **Confidence score:** 60/100
- **Last analyzed:** Sun Dec 14 2025 01:05:47 GMT-0500 (Eastern Standard Time)
### **Qualifications & scope**
- **Submission types:** 510k-traditional
- **Device classes:** class-i, class-ii
- **Specialties:** regulatory strategy, general-hospital
- **Device panels:** general-hospital
- **Regulatory pathways:** 510k
- **Type:** firm
- **Company:** Intertek
- **Years of experience:** 15
- **Regions served:** US, EU
- **Location:** United States
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** Intertek offers FDA 510(k) consulting services, focusing on efficient navigation of the submission process. Their expertise lies in helping companies achieve market success through FDA clearance.
- **Unique value:** Intertek provides efficient FDA 510(k) submission support to help medical device companies achieve market success.
- **Ideal projects:** The ideal client is a medical device company seeking FDA 510(k) clearance and looking for guidance through the submission process. This includes companies needing assistance with regulatory strategy and efficient market access.
- **Confidence score:** 60/100
- **Last analyzed:** Sun Dec 14 2025 01:05:47 GMT-0500 (Eastern Standard Time)
### **Qualifications & scope**
- **Submission types:** 510k-traditional
- **Device classes:** class-i, class-ii
- **Specialties:** regulatory strategy, general-hospital
- **Device panels:** general-hospital
- **Regulatory pathways:** 510k
Key Highlights
- Intertek offers FDA 510(k) consulting services, focusing on efficient navigation of the submission process. Their expertise lies in helping companies achieve market success through FDA clearance.
- Intertek provides efficient FDA 510(k) submission support to help medical device companies achieve market success.
Certifications & Trust Signals
- 15 years experience
Buyer Snapshot
Best for
- The ideal client is a medical device company seeking FDA 510(k) clearance and looking for guidance through the submission process. This includes companies needing assistance with regulatory strategy and efficient market access.
HQ:
United States
Languages:
English
Status:
listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment, 510(k) Strategy & Authoring, Predicate Research & Substantial Equivalence Strategy
Pathways Supported:
Traditional 510(k)
Device Types Supported:
Medical device
Supports Predicate Research:
Yes
Years Experience:
15
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Device Panels:
general-hospital
Engagement Models:
fixed_fee
Accepting New Clients:
No
