Regulatory Technology Services, LLC

Consulting Firm

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) submiss...

Experience: 12+ years

Professional Overview

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 success...

Core Specializations

Best suited for

• • MedTech companies seeking expert regulatory guidance

Experience signals

• Background: 12+ years of regulatory experience.

Cruxi view

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.

This analysis is generated by Cruxi AI using public information and may not capture the full scope of the consultant's experience.