Global Market Access Consulting for Medical Devices

View our global Market Access services

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.

Chart Your Course to New Markets with our 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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Choose Your Path for Market Growth.

Scalable RA/QA SaaS solution for medical device and IVD manufacturers

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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

Global Registration Consulting for Medical Devices and IVDs

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.

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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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India Authorized Agent for Medical Device Companies

Explore how we can support you by becoming your India Authorized agent for your medical devices and IVDs.

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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.

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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

ISO 13485:2016 is coming! Let Emergo help you transition from ISO 13485:2003 or ISO 13485:2012. Local offices throughout the US, Canada, Europe and Asia.

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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?

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ISO 14971 Risk Management Training for Medical Device Companies

Learn about Emergo by UL's ISO 14971 risk management training courses for medical device companies.

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Global Services

Certificate of Free Sale (CFS) for Medical Device Exports

Chart Your Course to New Markets with our Regulatory Affairs Management Suite

Choose Your Path for Market Growth.

Customized Regulatory Pathway Reports for Smaller International Markets

Global Registration Consulting for Medical Devices and IVDs

Independent Regulatory Representation for Medical Device Companies

India Authorized Agent for Medical Device Companies

ISO 13485 Audits for Medical Device Companies

ISO 13485 Consulting and Implementation for Medical Device Manufacturers

ISO 13485:2016 Consulting and Gap Analysis

ISO 14971 Risk Management Consulting for Medical Device Companies

ISO 14971 Risk Management Training for Medical Device Companies

Request information from our specialists

Thank you! We've received your request.

Global Services

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Certificate of Free Sale (CFS) for Medical Device Exports

Chart Your Course to New Markets with our Regulatory Affairs Management Suite

Choose Your Path for Market Growth.

Customized Regulatory Pathway Reports for Smaller International Markets

Global Registration Consulting for Medical Devices and IVDs

Independent Regulatory Representation for Medical Device Companies

India Authorized Agent for Medical Device Companies

ISO 13485 Audits for Medical Device Companies

ISO 13485 Consulting and Implementation for Medical Device Manufacturers

ISO 13485:2016 Consulting and Gap Analysis

ISO 14971 Risk Management Consulting for Medical Device Companies

ISO 14971 Risk Management Training for Medical Device Companies

Request information from our specialists

Thank you! We've received your request.