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ISO 13485:2003 is a company level certification based on a standard developed and published by the International Organization for Standardization (ISO) titled “Medical Devices-Quality Management Systems-Requirements for Regulatory Purposes”. ISO 13485:2003 is a certification intended for organizations that provide medical devices.

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Optimation Technology, Inc. - Rush, NY
Manufacturer, Custom Manufacturer, Service Company
ISO 9001:2008 certified custom manufacturer of process control software. Applications include custom manufacturing execution systems, product test data collection systems & laboratory test systems. Services include engineering, automation, installation, training, designing, fabrication & construction.
www.optimation.us/SoftwareEngineering.aspx
                                                                                                                                                                                                       
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