Advanced Certificate in Mastering ISO 13485 Requirements
-- ViewingNowThe Advanced Certificate in Mastering ISO 13485 Requirements is a comprehensive course designed for professionals seeking expertise in the medical device industry. This certification focuses on the ISO 13485 standard, a crucial requirement for quality management systems in this field.
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โข Understanding ISO 13485:2016
โข Scope and Application of ISO 13485
โข Key Differences between ISO 9001 and ISO 13485
โข Quality Management System (QMS) Requirements
โข Management Responsibility in ISO 13485
โข Resource Management for Medical Devices
โข Manufacturing Processes and Controls
โข Measurement, Analysis, and Improvement
โข CAPA and Preventive Actions in Medical Device QMS
โข Product Realization and Post-Market Surveillance
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