Luisa Gutiérrez, Medisi America CEO

LEADERSHIP EXPERIENCE

Experienced leadership behind every approval pathway.

Experienced leadership behind every approval pathway.

Experienced leadership behind every approval pathway.

Led by Luisa Gutiérrez, Medisi America brings decades of practical regulatory experience to medical device companies entering Latin America and the USA. The company’s history since 1980 gives clients a senior partner for strategy, representation, and local-market decisions.

Medisi America established since 1980

Specialized in medical device regulatory pathways

Leadership profile available on LinkedIn

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GLOBAL PRESENCE & ALLIANCES

A direct and trusted network for international market access.

A direct and trusted network for international market access.

A direct and trusted network for international market access.

Medisi America connects operational presence in Mexico and the United States with trusted partners and alliances across key global healthcare markets.

Medisi America connects operational presence in Mexico and the United States with trusted partners and alliances across key global healthcare markets.

Global presence and alliances map showing Houston, Tijuana, Cabo, CDMX, Brazil, Asia, trusted partners and alliances.

Direct presence

Houston, Tijuana, Cabo and CDMX support clients with local proximity, operational continuity and regional fluency.

Trusted alliances

Strategic partners in Brazil and Asia extend Medisi America’s ability to serve manufacturers across borders.

A personal note from our ceo

Every approval is personal. Behind every product is a patient who could be someone we love.

© 2026 MEDISI America · Medical device regulatory consulting for COFEPRIS ANVISA INVIMA FDA NMPA

© 2026 MEDISI America · Medical device regulatory consulting for COFEPRIS ANVISA INVIMA FDA NMPA