Global Services

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.

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Choose Your Path for Market Growth.

Explore new markets with regulatory insights categorized by country, device type, and device class.

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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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.

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ISO 13485 Audits for Medical Device Companies

The purpose of quality audits is to verify that manufacturing, development, and related control facilities meet current good manufacturing processes (GMP), as well as conform to the commitments of ISO 13485.

ISO 13485 Consulting and Implementation for Medical Device Manufacturers

ANSWERED ON THIS PAGE:

Why do we need ISO 13485 certification?
How will ISO 13485 certification benefit our company?
What is involved in the implementation process?

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

ANSWERED ON THIS PAGE:

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 and IVD Registration in 20+ Countries Worldwide

Commercializing your medical device first requires you to obtain registration and approval from regulatory agencies in each country where you plan to sell your device.

US FDA rolls out notification requirements to protect medical device supply chains

Obtaining a Medical Device CFG (Certificate to Foreign Government) from FDA

Emergo can help you obtain a CFG (Certificate to Foreign Government) so that you can show proof of FDA compliance in many markets worldwide.

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QMS Compliance for Startup Medical Device Companies

Startups need a quality management system (QMS) for medical devices well before products are shipped. Emergo can help you comply with US FDA and European regulations so you don't run into problems during registration.

Regulatory Affairs Management Suite

RAMS can help you navigate complex medical device and IVD regulatory affairs activities with powerful tools to simplify your work and provide market insights.

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Short Term or Part-time Medical Device QA/RA Outsourcing

Emergo provides short term quality assurance (QA) and regulatory affairs (RA) outsourcing for assistance with medical device registrations, QMS compliance, vigilance reporting and more.

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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.