WALTHAM, Mass., July 18, 2011 (GLOBE NEWSWIRE) -- BG Medicine, Inc. (Nasdaq:BGMD), a company focused on the development and commercialization of novel, biomarker-based diagnostics, announced today that it has received certification from the International Organization for Standardization (ISO) for meeting the requirements of the ISO 13485:2003. ISO 13485 is internationally recognized as the quality standard for the design, development, production and sale of medical devices.
ISO 13485 provides a comprehensive quality management framework for the design and manufacture of medical devices. Some of the specific requirements included in the ISO 13485 standard consist of inspection and traceability, process documentation and validation, and verification of the effectiveness of preventative or corrective actions.
"Receipt of ISO 13485 certification demonstrates BG Medicine's commitment to stringent quality systems and practices in the development and manufacturing of our diagnostic products such as the BGM Galectin-3™ test for heart failure," said Pieter Muntendam, MD, President and CEO of BG Medicine, Inc.
About BG Medicine, Inc.
BG Medicine, Inc. (Nasdaq:BGMD) is a life sciences company focused on the discovery, development, and commercialization of novel, biomarker-based diagnostics to improve patient outcomes and contain healthcare costs. The Company recently launched the BGM Galectin-3TM test for heart failure, the first novel blood test for cardiac disease cleared by the U.S. F.D.A. in five years. BG Medicine also has products in development to aid in the diagnosis and management of acute atherothrombosis and lipid disorders. For additional information about BG Medicine and galectin-3 testing, please visit www.bg-medicine.com and www.galectin-3.com.
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