Applied Technical Services (ATS)

Regulatory Consultant

Applied Technical Services is a consulting firm specializing in FDA 510(k) regulatory consulting. With 12 years of experience, they provide comprehensive support for medical device companies seeking 510(k) clearance across all device classes (I, II, and III). Their services include 510(k) consulting and in-house testing lab capabilities.

Experience: 12+ years

Submissions: 10 510(k)

Professional Overview

Applied Technical Services is a consulting firm specializing in FDA 510(k) regulatory consulting. With 12 years of experience, they provide comprehensive support for medical device companies seeking 510(k) clearance across all device classes (I, II, and III). Their services include 510(k) consulting...

Core Specializations

Best suited for

• • MedTech companies seeking expert regulatory guidance

Experience signals

• Regions: US
• Background: 12+ years of regulatory experience.

Cruxi view

Applied Technical Services (ATS) offers a compelling value proposition by combining 510(k) regulatory consulting with in-house testing lab capabilities. With 12 years of experience, ATS provides comprehensive support for medical device companies seeking 510(k) clearance across all device classes (I, II, and III). Their fixed-project pricing structure offers predictability for clients, and their focus on traditional 510(k) submissions suggests a streamlined and efficient approach to this common regulatory pathway. The integration of testing services and consulting provides a single point of contact for both regulatory strategy and necessary testing, potentially accelerating 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.