ANSI/AAMI/ISO TIR14969:2004

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Quality management systems - Medical devices - Guidance on the application of ISO 13485:2003

Provides guidance on the application of requirements contained in ISO 13485:2003, including detailed guidance related to process validation, design control, and quality planning.

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Association for the Advancement of Medical Instrumentation [aami]

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Quality management systems - Medical devices - Guidance on the application of ISO 13485:2003

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ANSI/AAMI/ISO TIR14969:2004

Quality management systems - Medical devices - Guidance on the application of ISO 13485:2003

Are the documents at the ANSI Webstore in electronic Adobe Acrobat PDF format only?

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