IntraOp Medical Obtains EN 46001/ISO 9001 for Mobetron

[December 2000]  Intraop Medical, Inc. announced that it has received EN 46001/ISO 9001 certification from British Standards Institution, Inc. (BSI, Inc.) for the design and manufacture of the Mobetron and its accessories. BSI, Inc. is recognized as the leading accredited registrar to ISO 9000 with over 33,000 registrations in over 90 countries. ISO 9001, originally published in 1987 by the International Organization for Standardization, is a generic quality systems standard that specifies, in very broad terms, the necessary components of a quality management system. ISO 9001 gives Intraop the tools to grow a better business through continuous improvement and refined processes.

Rick Belford, Intraop Director of Quality Assurance/Regulatory Affairs, comments "Organizations certified to the ISO 9000 quality system standard are known for their consistency, reliability, value, and customer service. A consistent quality management system assures that the qualities of Intraop's products are continuously improving to meet the quality and reliability demands of our customers."

EN 46001 is a medical guidance standard that leans on ISO 9001, and is not a stand alone quality system standard. EN 46001 has additional requirements specific to the medical device industry for certain elements such as process controls, traceability, and record retention, which are more critical for the medical device industry.

"This certification is Intraop's first step in obtaining our CE Marking, which is the European Union requirement to sell medical devices internationally. CE Marking shows that Intraop has demonstrated that they meet the design, manufacture, test and quality requirements of all applicable directives." states Mr. Belford.