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
**Who they are**
Regulatory Technology Services, LLC is a provider with 12 years of experience specializing in FDA 510(k) consulting and accredited third-party review. They focus on expediting 510(k) clearances for clients.
**Expertise & scope**
* FDA 510(k) Consulting
* Accredited Third-Party Reviewer
* Expedited 510(k) Clearances
* FDA 3P510K Review Program
**Reputation / proof points**
* 12 Years Experience
Regulatory Technology Services, LLC is a provider with 12 years of experience specializing in FDA 510(k) consulting and accredited third-party review. They focus on expediting 510(k) clearances for clients.
**Expertise & scope**
* FDA 510(k) Consulting
* Accredited Third-Party Reviewer
* Expedited 510(k) Clearances
* FDA 3P510K Review Program
**Reputation / proof points**
* 12 Years Experience
Additional information
Regulatory Technology Services, LLC offers specialized services focused on the FDA 3P510K Review Program, aiming to expedite the clearance process for medical devices. Their experience spans over a decade, providing clients with a dedicated resource for navigating the complexities of 510(k) submissions. The company emphasizes a streamlined approach to third-party reviews, which can be a critical factor for manufacturers seeking timely market access.
Key Highlights
-
12 Years Experience in FDA 510(k) Consulting & Third-Party Review
Source
“FDA 510(k) Consulting & Accredited Third Party Reviewer | 12 Years Experience”
Buyer Snapshot
Best for
- Medical device manufacturers seeking expedited 510(k) clearances
- Companies looking for accredited third-party review of low-to-moderate risk devices
How engagement typically works
- Direct engagement for review services
- Voluntary participation in the FDA 3P510K Review Program
Typical deliverables
- Accredited 510(k) reviews
- Consulting on FDA 510(k) submissions
Good to know
- Best when seeking an alternative to direct FDA submission for eligible devices.
HQ:
United States
Languages:
English
Claim status:
Listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
510(k) Strategy & Authoring, 510(k) eSTAR Preparation, Traditional 510(k) Support, Special 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 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
Supports Estar:
Yes
Supports Rta Remediation:
Yes
Supports Labeling Review:
Yes
Provides Submission Project Management:
Yes
