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What is ISO 13485 (DIN EN ISO 13485 2012, etc.)? What is ISO 13485? ISO 13485 (and derivatives such as DIN EN ISO 13485) is an internationally recognized quality management system for medical devices. ISO 13485 2012 is ...
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ISO 13485 Arguably, the most substantial success of the GHTF’s regulatory harmonization efforts has centered around the ISO 13485 standard, “Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes.” This standard has been officially ...
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