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ISO 13485 requires that organizations establish and Implement effective monitoring measurement analysis and Improvement processes these processes are essential for demonstrating product Conformity maintaining the effectiveness of the quality management system and ensuring consistent product quality the standard emphasizes careful planning of methods including statistical techniques to enable accurate assessment and Improvement of processes and product characteristics key requirements include systematic feedback collection on customer requirements structured complaint handling rigorous internal Audits and comprehensive data analysis these measures form the basis for continuous Improvement efforts including corrective actions and preventive actions to maintain the suitability adequacy and effectiveness of the quality management system while enhancing medical device safety and performance

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