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Medical Component Specialists (MCS) is preparing to launch a new state of the art manufacturing facility in Costa Rica. By the end of 2Q26, the site will be ISO 13485 validated. MCS is already an FDA-registered organization, following a successful FDA audit in 2018.
Located five miles from the main port, in the free trade zone outside Orotina, MCS’ 16,000-square-foot manufacturing site plans to open this summer. The facility, operating with MCS’s proprietary, fully automated grinding process, combines custom engineering and process IP that’s been in development for the past three years.
Costa Rica has become a global medical device hub with over 70 (and growing) major manufacturers, robust suppliers, and proven FDA-compliant operations. The country is home to strong STEM education and experienced cleanroom talent at significantly lower labor costs than in the U.S. or EU. Companies operating within the free trade incentive zones enjoy 0% tax for up to 12 years, plus exemptions on equipment, raw materials, and exports. Further, Costa Rica is close to the U.S., within stable time zones, and offers a mature logistics infrastructure optimized for medical devices.
During the first phase of launch, five custom grinding centers will offer manufacturers in Costa Rica an immediate cost savings of 30%, with plans to add 45 more. The technology features a fully automated cleaning system for both metals and plastics. The site is designed to support production volumes of up to 20,000 units per month, with scalability built in to accommodate long-term growth and supply chain redundancy.
Source: Medical Component Specialists
