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ISO 13485 especifica los requisitos de los sistemas de gestión de calidad (QMS) para la industria de dispositivos médicos. Se basa en los requisitos de la norma más general ISO 9001: 2000, en el contexto de esta industria. El título exacto de la norma ISO 13485: 2016 es Dispositivos médicos - Sistemas de gestión de la calidad - Requisitos para fines reglamentarios. ...
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