“The ISO 13485 certification is a strong complement to our existing ISO 9001:2008 and AS9100C certifications, allowing us to further demonstrate our commitment to quality and customer satisfaction,” said Jay Jackson, manager, quality and training.
First published in 1996, ISO 13485 ensures that medical device manufacturers design quality management systems to maintain the effectiveness of their processes. The standards cover all lifecycle stages of a medical device.
To achieve the certification, Prime underwent thorough reviews of its quality management system, including observations of business processes, reviews of supporting documentation, and reviews of the culture of quality in the company.
“At Prime, we strive to create a culture of continual improvement and this certification is the next step as we continue to grow and expand our business offerings,” said Greg Chesnutt, president and CEO. “With today’s market demanding superior service and support, the ISO 13485 certification builds upon our already strong reputation as a quality manufacturing partner.”
Prime Technological Services is a contract manufacturer specializing in printed circuit board assemblies (PCBAs) and top-level box build. A leader in high-mix, high-complexity projects, Prime has the systems and processes in place to increase throughput and reduce cycle times—from a single, quick-turn prototype to turn-key management of an entire portfolio of moderate-to-high volume products. Companies who have worked with Prime include Eaton, Emerson Electric and Landis+Gyr.