Electrochem Solutions, Inc., a subsidiary of Greatbatch, Inc. (NYSE:GB), completed its ISO 13485:2003 registration audit, conducted by the National Standards Authority of Ireland (NSAI), and received recommendation for certification.
ISO 13485:2003 certification specifies processes for an organization’s quality management system to demonstrate the ability to provide medical devices and related services that consistently meet regulatory and customer requirements pertaining to medical device application standards. Electrochem specializes in technology solutions for critical missions where failure is not an option. This certification, coupled with Electrochem’s recent acquisition of Micro Power Electronics, an organization that is also ISO 13485:2003 certified, is a testament to Electrochem’s long-term commitment to the portable medical marketplace.
“We are thrilled to have earned this recognition because of the hard work and dedication our associates have shown to make Electrochem a world-class organization. This certification proves our commitment to quality for portable medical devices, of which we provide enabling power,” said Kevin Christopher, Director of Quality, Electrochem. “And, we firmly believe that by having high standards across all of our business processes, our customers will benefit from our ability to consistently meet their expectations and facilitate continued growth.”
Electrochem expects final certification to be delivered over the next six weeks.About Electrochem Solutions, Inc. and Greatbatch, Inc. Electrochem, founded in 1979, is a world leader in the design and manufacture of customized battery and wireless sensing technology solutions. A subsidiary of Greatbatch, Inc., Electrochem was born from the lithium battery invented for the implantable pacemaker by founder, Wilson Greatbatch. Today, Electrochem is known for providing reliable products which are used across a range of critical applications in the portable medical, energy, military, aerospace, environmental and process control industries. Greatbatch, Inc. (NYSE: GB) provides top-quality technologies to industries that depend on reliable, long-lasting performance through its brands -- Greatbatch Medical, Electrochem and QiG Group. Greatbatch Medical develops and manufactures critical medical device technologies for the cardiac, neurology, vascular and orthopaedic markets. Electrochem designs and manufactures custom battery and wireless sensing technologies for high-end niche applications in the energy, military, portable medical, and other markets. The QiG Group empowers the design and development of new medical devices for the company’s core markets.