MICRO’s Costa Rica Facility Achieves ISO 13485:2016 Certification

MICRO’s Costa Rica facility has successfully implemented a Quality Management System in accordance with ISO 13485:2016. The facility is located in the Zona Franca Metro business park.
 
According to ISO (International Organization for Standardization), this standard is based on several quality management principles including a strong customer focus, the motivation and involvement of top management, a process-based approach, and continuous improvement. Operating to ISO standards ensures that customers get consistent, high-quality products and services, which helps create a virtuous cycle for customers, patients, and suppliers.
 
“This certification validates MICRO’s commitment to delivering the highest quality medical device products, which reduces risk for our customers and delivers optimal outcomes for patients,” MICRO President Brian Semcer said. “We are proud of the team effort put forth by our employees in New Jersey and Costa Rica, which resulted in successfully completing the rigorous process to receive this critical certification. By implementing ISO 13485:2016, we can confidently manufacture to this exacting quality standard, which we believe is necessary when working in global markets.”
 
The Costa Rica facility opened late in 2021 and includes new clean room assembly space within the manufacturing center. This expansion, combined with three facilities in New Jersey and strategic sourcing partnerships worldwide, allows MICRO to provide ncreasing capabilities and solutions to customers through supply chain optimization and integration.
 
MICRO’s medical device division began 40 years ago, developing ligation clips for use in surgical procedures and has grown to produce more than 1 million endoscopic instruments annually in its environmentally controlled Class 8 clean room. MICRO’s Design for Manufacturability expertise allows the company to help customers design components and assemblies that are optimized for production, keeping costs manageable and maximizing return on investment. MICRO is a full-service contract manufacturer of precision medical devices, injection/insert/metal injection molding, fabricated tube assemblies, sub-assemblies, and complete devices. With more than 75 years of manufacturing excellence, MICRO offers product development, design assistance, prototyping, validation support & full-scale production. MICRO utilizes modern manufacturing techniques and innovative engineering solutions to consistently deliver high-quality single-use medical devices.