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ISO 13485 Medical Device

ISO 13485 Internal Auditor Training

This three-day program is designed for quality professionals with a knowledge of medical device manufacturing.  The objective of the course is to teach, through lectures, workshops and exercises, how to plan, conduct and report internal audits that are compliant for the medical device industry. In so doing participants will review the new 2003 standard from an auditor’s perspective, highlighting the changes from the former version. In addition, the concepts of ISO 14971 - The Medical Device Risk Management Standard - will be introduced.