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Course Description

In the field of medical products, devices, and components, regulatory requirements and customer expectations are demanding. Throughout the world, manufacturers and their suppliers are expected to comply with the highest standards and regulations. ISO 13485-�Medical devices is the standard for organizations engaged in the manufacture of medical devices. Designed for new and current auditors interested in sharpening their auditing skills, participants will acquire the necessary skills to become a leader in preparing and conducting 1st and 2nd party audits to ISO 13485. This course includes a simulated audit, based on documentation from an actual organization, so participants can develop and refine their newly acquired knowledge and skills.
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