Regulatory Technology Services, LLC
FDA 510(k) Consulting & Accredited Third Party Reviewer | 12 Years Experience
Regulatory Technology Services, LLC is a dedicated consulting firm specializing in FDA 510(k) regulatory consulting. As a highly active FDA-accredited 510(k) Third Party Reviewer, they provide expert guidance to medical device companies seeking to navigate FDA regulatory pathways and achieve successful 510(k) clearances. Their expertise is focused on ensuring efficient and effective 510(k) submissions.
About
Regulatory Technology Services, LLC is a dedicated consulting firm specializing in FDA 510(k) regulatory consulting. As a highly active FDA-accredited 510(k) Third Party Reviewer, they provide expert guidance to medical device companies seeking to navigate FDA regulatory pathways and achieve successful 510(k) clearances. Their expertise is focused on ensuring efficient and effective 510(k) submissions.
Additional information
### **Additional information**
- **Type:** firm
- **Company:** Regulatory Technology Services, LLC
- **Years of experience:** 12
- **Location:** United States
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** With 12 years of dedicated experience, Regulatory Technology Services, LLC offers a uniquely powerful advantage in FDA 510(k) regulatory consulting. Their most significant differentiator is their status as a highly active FDA-accredited 510(k) Third Party Reviewer, providing an invaluable, insider's perspective on FDA expectations and review processes. This dual role ensures clients benefit from current, direct insights into what makes a 510(k) submission successful, specifically for Class I and Class II general hospital devices. Their expertise is laser-focused on navigating the traditional 510(k) pathway, making them exceptionally adept at streamlining the clearance process.
- **Unique value:** Regulatory Technology Services, LLC stands out as an FDA-accredited 510(k) Third Party Reviewer, offering clients an unparalleled, insider's understanding of FDA review processes and expectations directly from an active reviewer's perspective, combined with 12 years of focused 510(k) consulting expertise.
- **Ideal projects:** The ideal client for Regulatory Technology Services, LLC is a medical device company developing Class I or Class II general hospital devices that require a traditional 510(k) clearance. Companies seeking to leverage an intimate understanding of FDA review criteria, gained from direct third-party review experience, would find this firm invaluable. Projects best suited involve navigating complex 510(k) submissions where efficiency, accuracy, and a high probability of success are paramount, particularly for those who appreciate a fixed-project pricing structure for predictable costs.
- **Confidence score:** 70/100
- **Last analyzed:** Sun Dec 14 2025 01:16:26 GMT-0500 (Eastern Standard Time)
### **Qualifications & scope**
- **Submission types:** 510k-traditional
- **Device classes:** class-i, class-ii
- **Specialties:** general-hospital, regulatory strategy, risk management
- **Device panels:** general-hospital
- **Regulatory pathways:** 510k
- **Type:** firm
- **Company:** Regulatory Technology Services, LLC
- **Years of experience:** 12
- **Location:** United States
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** With 12 years of dedicated experience, Regulatory Technology Services, LLC offers a uniquely powerful advantage in FDA 510(k) regulatory consulting. Their most significant differentiator is their status as a highly active FDA-accredited 510(k) Third Party Reviewer, providing an invaluable, insider's perspective on FDA expectations and review processes. This dual role ensures clients benefit from current, direct insights into what makes a 510(k) submission successful, specifically for Class I and Class II general hospital devices. Their expertise is laser-focused on navigating the traditional 510(k) pathway, making them exceptionally adept at streamlining the clearance process.
- **Unique value:** Regulatory Technology Services, LLC stands out as an FDA-accredited 510(k) Third Party Reviewer, offering clients an unparalleled, insider's understanding of FDA review processes and expectations directly from an active reviewer's perspective, combined with 12 years of focused 510(k) consulting expertise.
- **Ideal projects:** The ideal client for Regulatory Technology Services, LLC is a medical device company developing Class I or Class II general hospital devices that require a traditional 510(k) clearance. Companies seeking to leverage an intimate understanding of FDA review criteria, gained from direct third-party review experience, would find this firm invaluable. Projects best suited involve navigating complex 510(k) submissions where efficiency, accuracy, and a high probability of success are paramount, particularly for those who appreciate a fixed-project pricing structure for predictable costs.
- **Confidence score:** 70/100
- **Last analyzed:** Sun Dec 14 2025 01:16:26 GMT-0500 (Eastern Standard Time)
### **Qualifications & scope**
- **Submission types:** 510k-traditional
- **Device classes:** class-i, class-ii
- **Specialties:** general-hospital, regulatory strategy, risk management
- **Device panels:** general-hospital
- **Regulatory pathways:** 510k
Key Highlights
- With 12 years of dedicated experience, Regulatory Technology Services, LLC offers a uniquely powerful advantage in FDA 510(k) regulatory consulting. Their most significant differentiator is their status as a highly active FDA-accredited 510(k) Third Party Reviewer, providing an invaluable, insider's perspective on FDA expectations and review processes. This dual role ensures clients benefit from current, direct insights into what makes a 510(k) submission successful, specifically for Class I and
- Regulatory Technology Services, LLC stands out as an FDA-accredited 510(k) Third Party Reviewer, offering clients an unparalleled, insider's understanding of FDA review processes and expectations directly from an active reviewer's perspective, combined with 12 years of focused 510(k) consulting expertise.
Certifications & Trust Signals
- 12 years experience
Buyer Snapshot
Best for
- The ideal client for Regulatory Technology Services, LLC is a medical device company developing Class I or Class II general hospital devices that require a traditional 510(k) clearance. Companies seeking to leverage an intimate understanding of FDA review criteria, gained from direct third-party review experience, would find this firm invaluable. Projects best suited involve navigating complex 510
HQ:
United States
Languages:
English
Status:
listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment, Device Classification Support, Predicate Research & Substantial Equivalence Strategy
Pathways Supported:
Traditional 510(k)
Device Types Supported:
Medical device
Supports Predicate Research:
Yes
Years Experience:
12
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Device Panels:
general-hospital
Engagement Models:
fixed_fee
Accepting New Clients:
No
