At SANRUBIO Medical Devices Consulting, we transform regulatory challenges into opportunities for success. Headquartered in Miami, with strategic presence in Buenos Aires and São Paulo, we are your trusted partner for navigating the complex regulatory landscape of medical devices in the United States.

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Our multidisciplinary team combines technical expertise with regulatory knowledge to deliver comprehensive and tailored solutions. From initial regulatory assessments to product preparation and registration with the FDA, we support our clients every step of the way.

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We understand that every medical device is unique, which is why we design strategies customized to meet your specific needs. Our services include assistance in implementing quality management systems in compliance with international standards such as ISO 13485, MDSAP, and 21 CFR 820, ensuring regulatory compliance and operational excellence.

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At SANRUBIO, our mission is to facilitate global market access while promoting quality and safety in every project. Contact us today to discover how we can be your strategic ally in the competitive world of medical devices.