Brazil Market Access for Medical Devices and IVDs

View our Brazilian Market Access services

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

ANVISA Medical Device and IVD Registration and Approval in Brazil

Emergo can assist you with Brazil ANVISA regulatory registration and approval to sell medical devices on the Brazilian market.

Brazil Registration Holder Service for Medical Device and IVD Companies

Learn what it means to choose Emergo by UL as your independent Brazil Registration Holder (BRH) for foreign medical device companies selling in Brazil.

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.

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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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.

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MDSAP Compliance: Medical Device Single Audit Program Consulting

Learn how using our internal and gap audit services to meet MDSAP specifications can improve your global market access efforts for medical devices and IVDs.

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