What services does Emergo by UL offer?

Emergo by UL offers Regulatory Pathway Assessment, 510(k) Submission Authoring, De Novo & PMA Strategy and other FDA regulatory consulting services for medical device companies.

What regulatory pathways does Emergo by UL specialize in?

Emergo by UL specializes in 510k, De Novo, Pma and other FDA regulatory pathways for medical devices.

What is Emergo by UL's regulatory experience?

Emergo by UL has 20+ years of experience, 10+ 510(k) submissions in FDA regulatory affairs.

Emergo by UL

Consulting Firm

Emergo by UL is a leading global QA/RA consulting firm dedicated to helping medical device companies successfully navigate complex FDA regulatory pathways. With a strong specialization in FDA 510(k) submissions, they have a proven track record of hundreds of cleared 510(k)s. Their comprehensive services extend to De Novo applications and PMAs, supporting clients in the US, EU, and globally. Levera...

Experience: 20+ years

Submissions: 10 510(k)

Expertise & Specializations

Regulatory Pathways

510kDe NovoPma

Executive Summary

Professional Overview

Core Specializations

Regulatory Pathways

510kDe NovoPma

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.

De Novo & PMA Strategy
Strategic planning and support for De Novo and PMA pathways, including clinical trial design and FDA meeting preparation.

Cruxi Independent Snapshot

Best suited for

• MedTech companies seeking expert regulatory guidance

Experience signals

Background: 20+ years of regulatory experience.

Cruxi view

Emergo by UL is a well-established regulatory consulting firm specializing in FDA 510(k) submissions. Their affiliation with UL suggests a focus on quality and safety, which could be valuable for clients seeking a thorough and reliable partner.

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

Contact Emergo by UL

Share a brief overview of your device and timeline. Cruxi will forward your request to Emergo by UL and help structure next steps.

Contact Now