ISO 13485 Training: Building Competence for Medical Device Quality

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2025-07-08 07:01:29 -

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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