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.
Together with Intertek Academy, we offer a 2-day course on EN ISO 13485:2016, 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.
💡 What you'll learn:
- The purpose and scope of ISO 13485 and its relationship to ISO 9001 and MDR/IVDR
- ISO 13485:2016 requirements
- How to design, deploy, and maintain your QMS
🎓 Led by Cilla Lundevall Wiberg, Principal Quality and Regulatory Consultant
📍 Next session: 15-16 April in Stockholm (English)
💰 Price: 14 300 SEK (excl. VAT)
📩 Learn more and register:
https://www.aurevia.com/courses/quality-management-system-according-to-en-iso-134852016-in-practice
Don’t miss this opportunity to learn how to build quality into every step of your medical device development journey.
