After 15 years inside one of the world’s most sophisticated MedTech clusters, MCI has become part of the testing, quality engineering and regulatory infrastructure that underpins the resilience of Costa Rica’s medical device supply chain

When multinationals evaluate a manufacturing location, the headline metrics come first: export volumes, workforce skills, regulatory environment and tax structure. Costa Rica clears them all.

The country recorded US$10 billion in medical device exports in 2025, according to the Central Bank of Costa Rica, making it the world’s largest per-capita exporter of medtech products. It is also home to 18 of the industry’s top 35 companies, most of them clustered in the Central Valley.

What the metrics do not show, however, is what happens on the production floor every day: the analytical work, the quality engineering and the regulatory documentation that keep a regulated manufacturer efficiently in compliance and in operation.

That is where MCI operates.

Founded in 2010 in Alajuela, Costa Rica, MCI is a testing and quality engineering platform that serves 95 per cent of the country’s medical device sector from two facilities totalling almost 27,000 sq ft (2,500 sq m). Its services cover the full analytical scope that regulated production demands: environmental monitoring, sterility testing in ISO-compliant cleanrooms, ethylene oxide residue analysis, microbial load and characterisation, and equipment and method validation. MCI’s client portfolio includes 75 MedTech companies, among which are 18 of the global industry’s top 35 manufacturers with operations in Costa Rica. These are companies that audit suppliers with the same rigour they apply to their own manufacturing operations.

“When MCI was founded, many manufacturers in Costa Rica relied on foreign laboratories in the United States or Europe, or built internal capabilities at significant cost,” Roberto Avila, co-founder and Business Development Manager of MCI, said. “We recognised that the future competitiveness of the country’s medtech industry would depend not solely on manufacturing excellence, but on a robust local supplier base capable of operating at the same standards required by global regulation. That was the gap we were built to close.”

Accredited under ISO/IEC 17025 and aligned with ISO 13485, the FDA’s Quality Management System Regulation, and the EU’s Medical Device Regulation, MCI integrates into clients’ quality chains at a depth most external providers do not reach. The company participates in risk assessments, supports regulatory submissions, assists with process investigations, and contributes to quality planning from the earliest stages of a production cycle. For manufacturers operating under FDA QMSR or EU MDR, that proximity carries measurable operational value. Sending samples abroad for external testing compresses production schedules, limits rapid troubleshooting, and adds logistical complexity that regulated environments absorb poorly.

MCI’s geographic reach has grown alongside its technical scope. Through its integration into AGQ Labs Group, a multinational testing, inspection and certification organisation with laboratories across the U.S, Europe, Latin America and Africa, the company extended analytical services to the Dominican Republic, a market where medical device manufacturing has expanded as multinationals diversify their Caribbean Basin production footprints. A manufacturer with operations in both countries can draw on MCI’s capabilities across both markets through a single provider relationship, with consistent methodology and regulatory alignment.

“The concept we use internally is ‘GLOCAL’ – global scale, local agility,” Avila said. “In an industry as regulated and operationally demanding as MedTech, manufacturers face quality challenges at both levels simultaneously. Some require immediate on-site support; others are inherently cross-border. We are built to respond to both through a single relationship.”

The value proposition built by MCI during the last 15 years has been based on the ability to transform data into a better decision (knowledge), consistency of performance under any circumstance (reliability), reduction of uncertainty (confidence), and the strategic value of physical, technical and organisational proximity (closeness). The latter qualities of the service enable manufacturers to protect patients, satisfy regulations, and create value in global markets.

The company is also investing in the infrastructure required by Costa Rica’s next industrial chapter. The country’s life sciences ambition has moved beyond manufacturing execution towards design and innovation, a transition that demands different quality capabilities than those built over the previous three decades. MCI has expanded into biocompatibility testing to support research and development teams evaluating new materials and prototypes, added GMP-compliant cleanroom space oriented toward biotechnology research, and digitalised its validation processes through tools that compress documentation turnaround from days to hours, integrating laboratory data with business intelligence platforms for real-time quality trending.

Costa Rica’s medtech cluster has developed over three decades into something more than a collection of foreign-owned factories in a favourable tax jurisdiction. It has the workforce depth, institutional knowledge, regulatory sophistication, and quality testing and engineering infrastructure that characterise a mature industrial platform. MCI has grown from within that environment, shaped by the same demands its clients face, and has become a fundamental part of what makes the ecosystem deliver confidence and reliability.

Further information
Produced with support from MCI. To find out more about its laboratory testing, quality engineering, validation and regulatory support services, visit www.mci-cr.com

READ MORE: BAC strengthens its strategic role in Costa Rica’s life sciences ecosystem. Central America’s largest banking group is deepening its role in Costa Rica’s fast-growing life sciences sector, supporting multinational medical device and specialised technology companies with financial connectivity, treasury services, employee benefits and regional advisory support.

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