Do you work with medical devices? Understanding and implementing a robust Quality Management System (QMS) is key to regulatory success—and often a prerequisite for CE-marking.
📅 Next session: Stockholm, Sweden, 1-2 December 2026 (held in English)
Our upcoming course covering Quality management system according to EN ISO 13485:2016 – in practice, in cooperation with Intertek Academy, is designed to help you interpret and apply the standard effectively. Whether you're in QA, development, production, or regulatory affairs, this course will give you the tools to build and maintain a compliant QMS.
This course covers:
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The purpose and scope of ISO 13485 and its relationship to ISO 9001 and MDR/IVDR
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ISO 13485:2016 requirements
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How to design, deploy, and maintain your QMS
Who should attend?
This course is intended for personnel within QA, development, production and management, as well as for internal auditors, process owners, and regulatory staff at companies within the medical device supply chain. A basic knowledge of quality systems, such as ISO 9001, 13485, GMP, etc. is recommended.
What you’ll learn
After the course, participants will have a basic understanding of the ISO standard and how to establish and maintain a quality management system based on it.
The course is held in English and led by Cilla Lundevall Wiberg, Medical Device QA/RA Expert.
Questions? Contact: academy@aurevia.com
Learn more and register
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