Spelman's factory in China has obtained ISO 13485:2003 and EN ISO 13485:2012 certification for medical device manufacturing equipment.
スペルマンハイ・ボルテージエレクトロニクスコーポレーション 日本支社
Spellman announced that its manufacturing facility in Suzhou, China has obtained ISO 13485:2003 and EN ISO 13485:2012 certification. The main purpose of ISO 13485:2003 is to establish the regulatory requirements for quality management systems related to the manufacture of medical devices and associated services. Both standards emphasize the maintenance of effective processes for regulatory requirements, custom requirements, risk management, and the safe design, manufacture, and distribution of medical devices. EN ISO 13485:2012 applies only to manufacturers placing medical devices on the European market, while ISO 13485:2003 remains the standard applicable to all other international markets, including the United States. As Spellman's hub in Asia, the Suzhou facility supports customers in Asia, South Asia, the Pacific Rim, and India. The Suzhou facility serves as a center for service and support for generators for digital radiography, mammography, C-arm Monoblocks, bone density measurement Monoblocks, and generators for computed tomography.
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