What services does Emergo by UL offer?

Emergo by UL offers Regulatory Pathway Assessment, 510(k) Submission Authoring, De Novo & PMA Strategy, QMS Setup & Implementation 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, Pma, De Novo and other FDA regulatory pathways for medical devices.

What is Emergo by UL's regulatory experience?

Emergo by UL has 12+ years of experience, 45+ 510(k) submissions in FDA regulatory affairs.

Emergo by UL

Emergo by UL's medical device RA/QA consultants guide you through the most efficient regulatory routes for approval and registration, ensuring worldwide post-market compliance. Avoid costly mistakes and delays in your market entry.

Experience: 12+ years

Submissions: 45 510(k)

Expertise & Specializations

Regulatory Pathways

510kPmaDe NovoIdeQ Sub

Device Specialties

CardiovascularNeurologyOrthopedicGeneral-Hospital

Executive Summary

Professional Overview

Core Specializations

Regulatory Pathways

510kPmaDe NovoIdeQ Sub

Device Specialties

CardiovascularNeurologyOrthopedicGeneral-Hospital

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.

QMS Setup & Implementation
Quality management system design, implementation, and validation to meet FDA and ISO requirements.

Post-Market Support
Post-market surveillance, adverse event reporting, and ongoing regulatory compliance support.

Cruxi Independent Snapshot

Best suited for

• MedTech companies seeking expert regulatory guidance

Experience signals

Background: 12+ years of regulatory experience.

Cruxi view

Emergo by UL assists medical device and IVD companies with regulatory affairs and quality consulting. They focus on efficient regulatory routes to market and maintaining post-market compliance worldwide. They are ISO 13485 certified.

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