What services does Acertara Labs offer?

Acertara Labs offers Regulatory Pathway Assessment, 510(k) Submission Authoring and other FDA regulatory consulting services for medical device companies.

What regulatory pathways does Acertara Labs specialize in?

Acertara Labs specializes in 510k and other FDA regulatory pathways for medical devices.

What is Acertara Labs's regulatory experience?

Acertara Labs has 20+ years of experience in FDA regulatory affairs.

Acertara Labs

Regulatory Consultant

Acertara Labs is a distinguished full-service CRO with 20 years of specialized experience in FDA 510(k) regulatory consulting. They possess profound expertise in ultrasound devices, having successfully managed hundreds of 510(k) submissions in this area, and also offer significant capabilities in implant devices. Acertara Labs guides medical device companies through FDA regulatory pathways, ensuri...

Experience: 20+ years

Expertise & Specializations

Regulatory Pathways

510k

Device Specialties

Radiology

Executive Summary

Professional Overview

Core Specializations

Regulatory Pathways

510k

Device Specialties

Radiology

Services Offered

Regulatory Pathway Assessment
Strategic assessment to determine the appropriate FDA regulatory pathway (510(k), De Novo, PMA) for your medical device.

510(k) Authoring & Submission
Complete 510(k) submission preparation, documentation authoring, and FDA submission management.

Cruxi Independent Snapshot

Best suited for

• MedTech companies seeking expert regulatory guidance

Experience signals

Background: 20+ years of regulatory experience.

Cruxi view

Acertara Labs is a uniquely valuable full-service CRO with 20 years of experience specializing in FDA 510(k) regulatory consulting. Their profound expertise in ultrasound devices, evidenced by successfully handling "hundreds of 510(k)s" in this specific area, alongside strong capabilities in implant devices, sets them apart. This firm offers comprehensive 510(k) services, guiding clients through the regulatory pathways for both Class II and Class III devices, particularly within the radiology specialty, ensuring successful clearances for companies globally.

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

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