Edition 1 · English
MDR & IVDR 2.0 Revision
Related courses
- MDR & IVDR 2.0 - What to expect and how to prepare
Professional development for medtech professionals
New technology enables you to optimize and simplify regulatory processes, automate technical documentation, and stay ahead. Develop the right mindset and acquire the skills for tomorrow's medtech departments.


Self-paced courses on medical device regulation and digitalization, from free introductions to meddevo product trainings.
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 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.
The essential training for new meddevo users: the reference-based data model and its collections, navigating and importing data, maintaining product data with the Inspector and Regulatory AI, technical documentation and traceability, approval workflows and documents, and everyday tips and settings.
Part 1 made the case for digitalizing. Part 2 is the how: what standardization and tidying up really demand, the two halves of meddevo and why uploading documents is not digitalizing, how your data is actually shaped (collections, entries, form fields, references), how data becomes documents through templates, and what the ideal workflow looks like from a single data change all the way to submission. Pass the final exam, earn your certificate.
What digitalization actually means for RA, QM and R&D in medtech, what staying analog really costs, and how to know if your company is ready. The official companion to the meddevo Regulatory Digitalization Playbook and the SPECTARIS Playbook 'Navigating the Medtech Digital and AI Journey'. Pass the final exam, earn your certificate.
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.
A no-code tour of how the eIFU Platform actually works — the catalogue, documents, the public search page, publishing, custom domains, print requests, roles and the most common support scenarios. Built for Customer Success and Support so you can confidently explain the product and unblock customers.
A comprehensive program designed to prepare regulatory affairs professionals for the digital transformation.
Self-paced learning modules covering digital tools, automation, and modern RA workflows.
Earn certificates that demonstrate your expertise in medtech digitalization.
Learn from leading professionals with decades of experience in regulatory affairs.
Editions of The Regulatory Room that go deeper with Academy courses.
Edition 1 · English
Related courses
Build the skills for tomorrow's medtech departments with self-paced courses, certificates and insights from industry experts.