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Amos Beau adicionou um novo artigo Educação
2025-06-26 11:20:16 -

ISO 13485 Internal Auditor Training: Ensuring Quality in Medical Device Manufacturing
Introduction 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...

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Amos Beau adicionou um novo artigo Educação
2025-07-08 07:01:29 -

ISO 13485 Training: Building Competence for Medical Device Quality
Introduction 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...

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