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.

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Due Diligence Services for Mergers and Acquisitions

Our due diligence services help medical device companies navigate complex regulatory requirements to avoid post-transaction complications.

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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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.

Meeting in front of a large information device about universal detection of genes in a specific biological sample.

ISO 13845 Audit and Training Services for Medical Device Companies

We assist medical device manufacturers with on-site ISO 13845 compliance audits, training services, and eQMS support to evaluate their QMS and GMP processes.

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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?

Image Of Medical Ventilator. Hospital Respiratory Ventilation. Patient Life Saving Machine

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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Local Authorized Representative for Medical Device Manufacturers

Emergo by UL can act as an independent, local authorized regulatory representative for medical device and IVD manufacturers seeking global market access.

M&A Regulatory Due Diligence Services for Medical Devices

Our expertise supports regulatory compliance that is seamlessly integrated into your M&A strategy, facilitating smooth transitions and helping to preserve the value of your transactions.

Medical Device Regulatory Intelligence

Do you sell medical devices but need market access help? Use our regulatory intelligence software to access process charts and global knowledge base tools.

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Medical Device Regulatory Pathway Support for Smaller International Markets

From Algeria to Zambia, we provide custom Regulatory Pathway Reports for almost every country in the world, including Latin America, Southeast Asia, and Africa.

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Global Services

Certificate of Free Sale (CFS) for Medical Device Exports

Due Diligence Services for Mergers and Acquisitions

Global Registration Consulting for Medical Devices and IVDs

ISO 13485 Consulting and Implementation for Medical Device Manufacturers

ISO 13485:2016 Consulting and Gap Analysis

ISO 13845 Audit and Training Services for Medical Device Companies

ISO 14971 Risk Management Consulting for Medical Device Companies

ISO 14971 Risk Management Training for Medical Device Companies

Local Authorized Representative for Medical Device Manufacturers

M&A Regulatory Due Diligence Services for Medical Devices

Medical Device Regulatory Intelligence

Medical Device Regulatory Pathway Support for Smaller International Markets

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

Due Diligence Services for Mergers and Acquisitions

Global Registration Consulting for Medical Devices and IVDs

ISO 13485 Consulting and Implementation for Medical Device Manufacturers

ISO 13485:2016 Consulting and Gap Analysis

ISO 13845 Audit and Training Services for Medical Device Companies

ISO 14971 Risk Management Consulting for Medical Device Companies

ISO 14971 Risk Management Training for Medical Device Companies

Local Authorized Representative for Medical Device Manufacturers

M&A Regulatory Due Diligence Services for Medical Devices

Medical Device Regulatory Intelligence

Medical Device Regulatory Pathway Support for Smaller International Markets

Request information from our specialists

Thank you! We've received your request.