Practical courses on medical device regulatory and digitalization. Watch selected lessons right here — create a free account to track progress, take the quiz, and earn a shareable certificate. Some courses are exclusive to meddevo customers.
The EU Commission has proposed the biggest overhaul of the MDR and IVDR since they took effect. Follow Vera, a Head of Regulatory Affairs, through the eight reform areas of COM(2025) 1023: what would change, what stays, where the legislative process stands — and what your team should (and should not) do about it today.
A practical, plain-language course for Regulatory Affairs and Quality Managers who want to stop shipping paper Instructions for Use. You'll learn the exact legal basis — Commission Implementing Regulation (EU) 2021/2226, consolidated with the (EU) 2025/1234 amendment — which devices qualify, what the Article 4 risk assessment must cover, what your eIFU website and service must deliver, and a step-by-step roadmap from paper to electronic. Told along the story of Sabine, an RA manager on a mission to retire her company's infamous paper IFU ("The Brick") — with fun facts that are real, legal facts that sound made up, and a happy ending involving a picture frame.
The day-to-day Writer course for eTD users. Learn how the Writer works as a stack of blocks, how the three trigger keys (/, @ and #) put live values and citations into your text instead of frozen copies, how structure and numbering are configured rather than typed, and how to keep a document's monitoring status clean so it is fit to send. Includes a hands-on sandbox with a real editor. Template building and dynamic-content configuration are covered in the key-user course.
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