Press Release

OnCore receives ISO 13485 Certification for medical device manufacturing

Springfield, MA, January 28, 2009 — OnCore Manufacturing Services today announced that it has received certification for the ISO 13485 Quality Management Standard for Medical Devices at its San Marcos and San Jose, CA facilities. The announcement certifies Oncore as an Electronic Manufacturing Service (EMS) provider of high quality devices for the Medical industry.

The ISO 13485 certification recognizes Oncore’s compliance with FDA Quality System Regulations and medical industry standards at its two California facilities. The two join OnCore’s Springfield, MA and Tijuana, Mexico facilities as ISO 13485 registered. The ISO 13485 registration recognizes OnCore as a highly efficient, cost-effective and stable organization with advanced manufacturing processes to deliver product and service quality.

“OEM clients in the medical industry understand the value of the ISO-13485 Certification,” said Daniel Perez, President and CEO of OnCore. “Having the certification at our two California facilities demonstrates our continued focus on serving the electronic medical device market and enhances OnCore’s reputation as an exceptional manufacturer of high quality, high complexity medical devices.”

OnCore’s ISO 13485 certification ensures highest quality for medical devices

ISO 13485:2003 was created by the International Organization for Standardization (ISO) as an international quality management standard for medical devices. Manufacturers of medical electronics must be certified with ISO 13485 in order to secure global business contracts.
ISO 13485:2003 supplements ISO 9001:2000 with additional requirements for the medical industry in the areas of design and process controls, special processes, traceability, record retention and regulatory actions. OnCore’s certification assures medical industry OEMs that it has met those requirements.

OnCore’s world-class approach to the manufacture of medical devices helps ensure patient safety and gives the Company a competitive edge in the manufacture of devices like medical and laboratory equipment, biomedical instruments, and implantable devices.

Recent process enhancements at OnCore include integrated inventory management and tracking software, additional staff training, and automated optical inspection equipment to monitor process quality and prevent production defects. OnCore has enhanced its processes and training to meet the specific needs of current and prospective clients.

Complete details of the ISO 13485:2003 standard may be viewed on the ISO website at http://www.iso.org/iso/catalogue_detail?csnumber=36786.

About OnCore Manufacturing Services

OnCore Manufacturing Services, LLC is a leading provider of high complexity electronic manufacturing services to international blue-chip defense, industrial, and medical companies. With manufacturing facilities in Springfield, MA, Longmont, CO, San Marcos and San Jose, CA and Tijuana, Mexico, OnCore is well positioned to provide complex electronics manufacturing services to its customers with a comprehensive list of compliance certifications and approvals. For more information, please visit www.oncorems.com.

This release contains certain forward-looking statements based on OnCore's current expectations, estimates, forecasts and projections about the operating environment and markets in which OnCore operates. These statements are subject to important assumptions, risks and uncertainties, which are difficult to predict and the actual outcome may be materially different from those contemplated in forward-looking statements. OnCore and the OnCore logo are trademarks of OnCore Manufacturing Services.

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Contact for OnCore Manufacturing Services
E-mail: info@oncorems.com
Website: www.oncorems.com



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