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Local expertise to help you navigate medical device and IVD regulatory requirements in Latin America
With teams of bilingual medical device regulatory experts in Mexico, Brazil, and throughout Latin America, Emergo by UL has the expertise and the presence to act as your regulatory partner. We can:
- Help you to strategize which markets may be appropriate for your healthcare product
- Liaise with local regulators and health authorities to identify the best regulatory pathway for your product, as well as clinical and testing requirements
- Provide authoritative guidance on product classification and submissions to government agencies
- Act as your in-country representative in Brazil, Mexico, Peru, Colombia, and Costa Rica
- Streamline regulatory processes and provide intelligence via the RAMS digital RA/QA platform
