February 18, 2009 – ContextVision said today it has gained ISO 13485:2003 certification as recognized by the International Organization for Standardization (ISO), reportedly the world’s largest developer and publisher of international standards.
ISO 13485:2003 specifies requirements for a quality management system. To gain certification, an organization must demonstrate the ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices. The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems.
For more information: www.contextvision.com