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March 2010
Ingen Technologies achieves ISO Certification

Ingen Technologies, an emerging provider of medical products has received certification from the International Organization for Standardization (ISO) for fulfilling the requirements of ISO 13485:2003. To accomplish this goal, Ingen worked with BSI Management Systems, a leading provider of independent third-party certification of quality management systems.

"This is a significant milestone for Ingen and we are proud of this accomplishment," said Scott Sand, CEO, "The ISO 13485:2003 certification assures our customers and partners of our commitment to quality, and in the quality of our innovative products and processes. Additionally, we are looking forward to the new markets and business opportunities that ISO 13485:2003 certification offers for our products in the global marketplace."

ISO 13485:2003 specifies requirements for a quality management system. Based on the ISO 9001 standard, ISO 13485 is an internationally-recognized management system standard for the medical device industry. However, the ISO 9001 elements on continuous improvement and customer satisfaction are replaced with maintaining system effectiveness and monitoring customer feedback in ISO 13485. The standard also adds risk management criteria and strengthens the requirements for process and software validation.

To obtain ISO 13485:2003 certification, an organization must demonstrate its ability to provide medical devices that consistently meet applicable customer and regulatory requirements. The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. All requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization.