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<p>This document provides guidance on the development, implementation and maintenance of a <i>risk management</i> system for <i>medical devices</i> according to ISO 14971:2019.</p>
<p>The <i>risk management</i> <i>process</i> can be part of a quality management system, for example one that is based on ISO 13485:2016<sup>[</sup><sup>24</sup><sup>]</sup>, but this is not required by ISO 14971:2019. Some requirements in ISO 13485:2016 (Clause 7 on product realization and 8.2.1 on feedback during monitoring and measurement) are related to <i>risk management</i> and can be fulfilled by applying ISO 14971:2019. See also the ISO Handbook: <i>ISO</i> <i>13485</i><i>:</i><i>2016</i> —<i> Medical devices </i>—<i> A practical guide</i><sup>[</sup><sup>25</sup><sup>]</sup>.</p>
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<p>This document provides guidance on the development, implementation and maintenance of a <i>risk management</i> system for <i>medical devices</i> according to ISO 14971:2019.</p>
<p>The <i>risk management</i> <i>process</i> can be part of a quality management system, for example one that is based on ISO 13485:2016<sup>[</sup><sup>24</sup><sup>]</sup>, but this is not required by ISO 14971:2019. Some requirements in ISO 13485:2016 (Clause 7 on product realization and 8.2.1 on feedback during monitoring and measurement) are related to <i>risk management</i> and can be fulfilled by applying ISO 14971:2019. See also the ISO Handbook: <i>ISO</i> <i>13485</i><i>:</i><i>2016</i> —<i> Medical devices </i>—<i> A practical guide</i><sup>[</sup><sup>25</sup><sup>]</sup>.</p>
