Cadence Earns Quality ISOs

Cadence Inc.’s Pittsburgh, Pa., facility has earned the ISO 13485:2012 and ISO 9001:2008 certification through certification body BSI Group. The former certifies the company’s quality management system for medical device manufacture, and the latter certifies the company’s general quality management system.

“ISO certification reaffirms our continuing commitment to quality throughout all levels of the organization and provides an added level of assurance to our customers that their products are handled under rigorous quality standards,” said Marc Mabie, vice president and general manager of the Pittsburgh facility.

Cadence’s new facility, which opened earlier this year, offers turnkey finished medical device assembly and sterilization management capabilities. At this location, Cadence offers a certified ISO Class 8 (100,000) clean room, clean room injection/over molding and laser welding, experienced supply chain management, final assembly, packaging, labeling, and sterilization services.

“Our quality management system is well balanced to meet the high quality standards that finished medical devices demand and also deliver efficient value to our customers,” said Scott Bednar, senior quality manager.

Cadence is headquartered in Staunton, Va., and provides medical device outsourcing solutions.