Arlington, Virginia--(Newsfile Corp. - June 25, 2026) - Building on a partnership launched five years ago to strengthen the region's world-class medical device sector, the Association for the Advancement of Medical Instrumentation (AAMI) is returning to Costa Rica this August with a three-day course on FDA's Quality Management System Regulation.

"Design and Development - Navigating and Implementing QMSR" will be held from August 25-27, 2026, offering medical device industry professionals comprehensive coverage of FDA's risk-based QMSR requirements as they apply to design and development. Registration is open now.

A Partnership Rooted in Global Manufacturing

When AAMI and the Costa Rican Investment Promotion Agency (CINDE) announced their partnership in 2020, the rationale was straightforward: Costa Rica had become the second-largest medical device exporter in Latin America. Twelve of the world's 30 leading medtech companies had established operations there, and many of them were already AAMI members.

The FDA's QMSR officially took effect in January 2026 and aligns closely with ISO 13485, the internationally recognized standard for medical device quality management systems. The new rule emphasizes risk-based decision-making throughout the QMS. For the many multinational companies with a presence in Costa Rica, QMSR compliance is not a distant regulatory concern, but an operational reality.

What the Course Covers

The three-day course goes well beyond a reading of the regulations. Attendees will engage in hands-on exercises, structured discussions with FDA representatives, and interactive activities designed to ground the regulatory requirements in real-world device examples. Topics include device design and development, software validation, statistical techniques, and how each of these activities shapes risk-based decision-making across the QMS.

"This is a course that goes beyond the regulations," added M.J. McLaughlin, Senior Director of Training at AAMI. "The course brings real-world examples and real applications. Our experienced faculty have worked with companies around the world, so they have amazing anecdotes to learn from. All this taking place in Costa Rica, which is not just a famed vacation spot, but a growing hub for medical device exports, is bound to be an incredible experience."

AAMI faculty undergo thorough vetting and are recognized leaders within the medical device industry. FDA representatives join the faculty team at public courses when available. Course materials include a printed copy of The Quality Management System Compendium - 5^th Edition, electronic versions of PowerPoint presentations and case studies, pertinent FDA documents, additional references, and access to the online exam.

Who Should Attend

The course is designed for professionals responsible for ensuring compliance with design and development requirements, including engineering, regulatory compliance, quality assurance, manufacturing, operations, and marketing. Whether attendees are new to the industry or seasoned veterans, the course aims to provide them with the knowledge to immediately impact their organization's QMS processes and procedures.

With Costa Rica's medical device sector continuing to grow in global significance, access to current, rigorous regulatory education has never been more important. AAMI's return to the region reflects both the depth of that partnership and the urgency of the regulatory moment.

"Design and Development - Navigating and Implementing QMSR" runs Aug. 25-27, 2026. Register now.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/302764

Source: Association for the Advancement of Medical Instrumentation