1. General Information This Standard Operating Procedure (SOP) outlines the approach we use for developing, training, and updating machine learning (ML) models for integration into our medical devices. Adhering to this process helps ensure that ML models are deployed and […]
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This document outlines your user needs, also known as “stakeholder requirements.” These form the initial stage of requirements mapping and represent the highest level of design input. Describe the broad requirements that your device must fulfill. Subsequently, these user needs
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This document outlines the activities related to development and maintenance. Correlation of Standard Requirements to Document Sections ISO 13485:2016 Section Document Section 7.3.2 Design and Development Planning 1, 2, 3, 7 Classes IEC 62304:2006 Section Document Section A, B, C
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