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Costa Rica ISO 13485 Certified


Oberg Costa Rica, an Oberg Industries company located near San Jose, Costa Rica, has recently achieved ISO 13485:2003 certification from the British Standards Institution (BSI). ISO 13485:2003 is the internationally recognized quality standard for the manufacture of medical devices. Adding this new certification to their existing ISO 9001 quality standards demonstrates that the company’s management is committed to manufacturing products with the highest level of traceability and quality control. As part of Oberg’s manufacturing excellence policy, the company established a quality management system to ensure that all medical device products made in Costa Rica as well as the U.S.A. are inspected by qualified staff at each step of the manufacturing process. “This important certification formalizes the processes we use every day to provide quality solutions for our customers and positions our company well for future growth,” commented Brian Stewart, Director of Quality and Continuous Improvement for Oberg Industries.

Oberg Medical , a wholly-owned subsidiary of Oberg Industries, was established to focus on manufacturing medical devices such as orthopedic implants, instruments, assemblies, and endoscopic surgical components. Oberg Medical expanded their medical device manufacturing at a new facility in Costa Rica just two years ago and continues to add new customers, people, and equipment to provide cost-effective manufacturing solutions to their customer partners around the world.

“We are exceptionally proud of the Oberg Costa Rica team for their efforts and contributions that were essential for achieving this certification in a relatively short period of time,” added Mr. Stewart.

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