United States

Certificate of Free Sale (CFS) for Medical Device Exports

Emergo has obtained CFS documents for many clients seeking medical device registration in Asian, Middle Eastern, and Latin American markets, and can procure a CFS on your behalf for your medical device.

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.

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Independent Regulatory Representation for Medical Device Companies

Emergo by UL offers qualified in-country representative and regulatory representation for over 500 medical device companies worldwide.

ISO 13485:2016 Consulting and Gap Analysis

ANSWERED ON THIS PAGE:

What are the deadlines for ISO 13485:2016 certification?
How should we approach the transition to ISO 13485:2016?
What are the biggest changes in ISO 13485:2016?

ISO 14971 Risk Management Consulting for Medical Device Companies

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What does ISO 14971 require?
How do I implement ISO 14971?
How do I apply the risk management system and concepts to my product?

Medical Device and IVD Registration and Approval in Thailand

Medical device and IVD registration with the Thai Food and Drug Administration (FDA). Get our local support for approval.

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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What are the requirements for the Medical Device Single Audit Program (MDSAP)?
Which countries are participating in the MDSAP?
How can we achieve MDSAP certification?

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?
When must we comply with UDI system requirements?
Which device classifications need to comply with UDI requirements?

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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

FDA 510(k) consulting for medical device submission and CDRH clearance. Learn about the FDA approval and the 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?

US FDA Form 483 and Warning Letter Analysis, Response, and Recovery

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What is an FDA Form 483?
What are the next steps after getting an FDA Form 483?
What is an FDA Warning Letter?
How can you recover from an FDA 483 or Warning Letter?

US FDA Medical Device Classification

The US Food and Drug Administration (FDA) uses this system to classify medical devices as Class I, II, or III based on increasing risk to the patient or user.