Medical Device Regulation Law training
Gain expertise in EU MDR for orthopedic implants and more. Cover device classification, clinical evidence requirements, supplier agreements, German liability regulations, and post-market obligations to minimise legal risks, safeguard patients, and ensure ongoing market compliance.

4 to 360 hours flexible workload
valid certificate in your country
What will I learn?
This training delivers a practical overview of MDR requirements, focusing on orthopedic implants and Germany. Explore device qualification, classification, clinical evidence, supplier and quality agreements, post-market surveillance, vigilance, and liability risks, then develop a solid plan for compliance and safe market entry.
Elevify advantages
Develop skills
- Master MDR classification for orthopedic implants with confidence.
- Plan clinical evidence including CER, PMCF, and investigations to meet MDR standards.
- Draft supplier contracts aligning quality, liability, and MDR obligations clearly.
- Set up efficient post-market surveillance, vigilance, and EUDAMED systems.
- Navigate German liability laws like ProdHaftG and BGB to manage risks.
Suggested summary
Before starting, you can change the chapters and the workload. Choose which chapter to start with. Add or remove chapters. Increase or decrease the course workload.What our students say
Your lessons are perfect. I purchased the one-year package and finally have the opportunity to follow various topics of interest without needing to change platforms... I'm grateful for everything you do, I've already recommended you to other people...

Giulio CarloDigital Marketing Student
I like how the lessons are straight to the point and how I can change chapters and skip content I don't need.

Mariana FerresPhotography Student
I like the content and the way videos are presented and transcribed, which speeds up the process!

Luciana AlvarengaNail Design Student
The platform is fast and simple to use. The diversity of content and complementary videos really help with learning.

André FelipePrompt Engineering Student
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