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Gowned technicians assembling and inspecting medical devices in a clean, modern Costa Rica manufacturing lab.

R&D and Compliance Insights

Practical guidance on medical devices, SaMD, and FDA/ISO compliance, tailored for teams building regulated products in Costa Rica’s growing ecosystem today.

Costa Rica MedTech News

Costa Rica MD Summit 2026

The Costa Rica MD Summit 2026 will bring together the country’s medical device ecosystem on Thursday, August 6, 2026, at the Costa Rica Convention Center. As the third edition of the summit, this event is designed to strengthen business connections, accelerate supplier development, and position Costa Rica as one of the most dynamic medical technology hubs in the region. Organized…

Laura López: The Economist Behind Costa Rica’s MedTech Boom

Laura López: The Economist Behind Costa Rica’s MedTech Boom You may know that Costa Rica has become a MedTech powerhouse but do you know that behind all these engineers and managers there is an economist thought leader helping shape the conditions for this economic miracle in the Americas? Laura López, CEO of PROCOMER (Costa Rica’s Foreign Trade Promotion Agency), represents…

Life Sciences Forum Costa Rica 2026

The Life Sciences Forum 2026, organized by CINDE, will bring together Costa Rica’s life sciences and MedTech ecosystem on Thursday, June 4, 2026, at the Costa Rica Convention Center. Returning for its 5th edition, the forum is positioned as one of the most important life sciences events in Latin America, designed to connect the full value chain and strengthen Costa…

Costa Rica MD Summit 2025

Costa Rica MD Summit 2025: Where the Future of Medical Devices Comes Together Costa Rica will become a key meeting point for the medical device industry on Tuesday, July 22, 2025, as the Costa Rica MD Summit 2025 brings together manufacturers, suppliers, innovators, and industry leaders at the CIC ANDE in Belén, San José. More than just an industry event,…

Welcome to Costa Rica MedTech

Hi, I’m Leo Jiménez. What I do Why I’m sharing this Costa Rica’s MedTech sector is already doing world-class work, and I want to help document where we are today and where we can go next. I’m sharing this page with humility, as a snapshot that will improve over time. What you’ll find here How you can help If you…

About

Leonardo Jimenez and team share what is happening with the MedTech sector in Costa Rica. They share hands-on experience from leading medical device and key learning from on-going projects and operations, helping Costa Rican teams navigate design controls, and market access while meeting FDA, EU MDR, and ISO 13485 expectations in practice.

A wide, eye-level photographic realism view of a modern cleanroom-style medical device assembly area, completely empty of people. Stainless steel worktables, neatly organized shelves of labeled components, and a row of compact diagnostic devices in various assembly stages line the space. Bright, even overhead LED lighting reflects subtly off glossy white floors and smooth equipment casings, creating a sense of clinical precision. A large glass window at the back reveals lush, out-of-focus green tropical foliage, hinting at a Costa Rican setting. The composition uses leading lines from the tables to draw the eye toward the window, with sharp focus throughout. The atmosphere is orderly, compliant, and forward-looking, emphasizing a professional medtech manufacturing environment that blends high-tech rigor with a tropical location.

Risk

Framework map showing PMI governance, IEC 62304 lifecycle controls, ISO 14971 risk management, FDA regulatory assessment, IMDRF SaMD QMS, agile guidance, and QMS design controls.
The frameworks are complementary: governance, risk, lifecycle control, regulatory assessment, and agile delivery.

End‑to‑end ISO 14971 implementation for new devices, integrating design controls, verification plans, and regulatory submission expectations.

Specialized analysis of software hazards, cybersecurity threats, and data integrity risks for SaMD and connected therapeutic platforms.

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