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Tag: quality management

ISO 13485

ISO 13485:2016 Guide for Medical Device Manufacturers

ISO 13485:2016 is an international standard that specifies requirements for a quality management system (QMS) for manufacturers of medical devices. The standard aims to ensure the safety and effectiveness of medical devices by introducing a risk-based approach to quality management.

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eQMS

Discover how to integrate AI Into Quality Management Workflows

The AI revolution brings unparalleled opportunities and challenges across all sectors, with life sciences and healthcare standing at the forefront due to their critical role in enhancing public health and quality of life. These areas hold immense potential for AI to make groundbreaking improvements but also face significant risks that cannot be ignored.

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