Lemo USA Achieves ISO 13485 Certification

Rohnert Park, Calif.-based Lemo USA Inc., a subsidiary of Lemo SA (headquartered in Ecublens, Switzerland), which designs and manufactures precision custom connection solutions, has achieved ISO 13485 certification for the design, manufacture and distribution of medical components and cable assembly to medical customers.
 
These certifications are accredited by SQS, Swiss Association for Quality and Management in partnership with IQNet.
 
ISO 13485 establishes requirements for a comprehensive quality management system for product design and development consulting services for the medical device market. ISO 13485 is based on the ISO 9001 format with additional requirements for design, special processes, environmental control, traceability, documentation records, and regulatory actions.
 
To become certified as ISO 13485 compliant, Lemo USA underwent a thorough evaluation process that included initial assessment, quality management system development, and a full management system documentation review.
 
“ISO 13485 certification is a significant milestone for LEMO USA”, said Dean Pohwala, general manager. “We believe that our decision to become ISO 13485 certified is a proactive one that not only anticipates the demands of our customers, but also demonstrates our commitment to providing quality services and safe products to all of our customers in the medical industry. Our ultimate goal is guaranteed customer satisfaction.”