This course is for anyone that wants to gain the knowledge and skills required to perform full system first, second and third-party audits based on ISO 13485, in accordance with ISO 19011 and ISO IEC 17021-1.
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This course is for anyone that wants to be part of the team that performs internal audits of part of their Quality Management System (QMS) based on ISO 13485.
This course is for anyone who needs to understand the requirements, including similarities, differences and key aspects of both the ISO 13485 standard and the FDA Quality System Regulation (21 CFR Part 820).
This course is for anyone looking to gain a comprehensive understanding of the core requirements of ISO 13485 and this highly interactive course can be completed anytime, anywhere (24/7).