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ISO 13485 Internal Auditor Training: Ensuring Quality in Medical Device ManufacturingIntroduction ISO 13485 is an internationally recognized standard that outlines the requirements for a quality management system (QMS) specific to the medical device industry. It ensures that organizations consistently meet regulatory and customer requirements while maintaining the highest standards of safety and performance. Internal auditors play a critical role in ensuring compliance with...0 Σχόλια 0 Μοιράστηκε 382 Views
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ISO 13485 trainingWhat is ISO 13485? ISO 13485 is a quality management system standard that is specific to the medical device industry. It helps manufacturers create products that are safe and effective for patients. To receive ISO 13485 certification, a company must demonstrate that it has a comprehensive quality management system in place. This system includes processes for the design, development,...0 Σχόλια 0 Μοιράστηκε 62 Views
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ISO 13485 Training: Building Competence for Medical Device QualityIntroduction In the highly regulated medical device industry, ensuring product safety, efficacy, and compliance with global standards is paramount. ISO 13485:2016, the international standard for quality management systems (QMS) specific to medical devices, provides a framework for organizations to meet these demands. However, implementing and maintaining an effective QMS requires a deep...0 Σχόλια 0 Μοιράστηκε 282 Views