United States

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We work with clients to solve their biggest challenges in regulatory affairs, quality assurance, and device risk mitigation.

Certificate of Free Sale (CFS) for Medical Device Exports

Emergo helps medical device companies secure Certificate of Free Sale (CFS) for medical device exports to countries around the world.

Customized Regulatory Pathway Reports for Smaller International Markets

In most major markets the path to medical device regulatory approval is well documented. The process may not be easy, but it is well understood. That’s not true in all countries, especially some countries in Latin America, Southeast Asia, Africa and the Mi

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FDA eMDR Adverse Event Reporting for Medical Device Companies

Medical device manufacturers selling products in the United States must comply with post-market reporting requirements outlined by the US Food and Drug Administration (FDA) and submit adverse events electronically to the FDA for review.

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FDA QSR Consulting (21 CFR 820) for Medical Device Manufacturers

Emergo by UL offers FDA QSR consulting for medical device and IVD companies to help support successful 21 CFR Part 820 implementation and compliance.

FDA Submission for Medical Devices and In Vitro Diagnostics (IVDs)

FDA submission consulting services for medical device and IVD companies. Get help with US FDA registration from Emergo by UL.

ISO 14971 Risk Management Consulting for Medical Device Companies

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How do I apply the risk management system and concepts to my product?

Medical Device Post-market Surveillance

Regulatory compliance doesn’t end when your device goes to market. We design compliance solutions informed by a life-cycle approach to device safety and effectiveness.

Medical Device Single Audit Program (MDSAP) Internal and Gap Audits

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Medical Device UDI Consulting and Training

Medical Device UDI (Unique Device Identification) Consulting and Training

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How does the US FDA UDI system work?
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Simplify Regulatory Documentation with Smart Builder

Smart Builders walk you through regulatory documentation for Brazil’s Registro Route, Mexico Equivalency Routes, US FDA 510(k), and Europe’s MDD, MDR, and IVDR.

US FDA 510(k) Consulting for Medical Devices and IVDs

US FDA 510(k) consulting for medical device submission and CDRH clearance. Learn about the FDA pre-market notification 510(k) submission process.

US FDA Agent Representation for Medical Device and IVD Companies

Appoint Emergo as your registered US FDA Agent representation and learn about our responsibilities as the liaison between your medical device or IVD company and the FDA.

US FDA Consulting for Medical Device and IVD Manufacturers

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Why does third-party FDA consulting make sense for some medical device companies?

COVID-19 pauses US FDA inspection plans, again

US FDA Pre-sub (Q-Sub) Consulting for Medical Devices

Emergo's experienced US consulting team has extensive expertise with the FDA Q-Sub process. We can guide you through this critical step toward FDA clearance.

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