Custom-Made Device Manufacturer training
This training provides a practical overview of EU MDR for custom-made orthopedic implants, covering classification, technical files, design controls, ISO 14971 risk management, 3D printing validation, labeling, IFU, and post-market surveillance to ensure compliance and traceability.
4 to 360h flexible workload
certificate valid in your country
What will I learn?
Gain focused insights into EU MDR for single-patient orthopedic implants, including legal definitions, classification, conformity assessment, and documentation. Build compliant technical files, apply design controls and ISO 14971 risk management, validate additive manufacturing, develop labeling and IFU, and handle post-market surveillance and complaints.
Elevify advantages
Develop skills
- Master EU MDR compliance by mapping custom orthopedic implant designs to regulatory requirements.
- Develop skills in creating ISO 14971 risk files, clinical evaluations, and technical documentation.
- Implement controls for additive manufacturing, including 3D printing qualification, materials, and NDT.
- Manage post-market surveillance with PMS plans, CAPA processes, and incident reporting.
- Design surgeon-focused workflows integrating inputs, labeling, and instructions for use.
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 are saying
Your classes are perfect. I purchased the one-year package and finally have the opportunity to follow various topics of interest without needing to switch platforms... I thank you 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.
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The platform is fast, simple to use. The diversity of content and complementary videos really help with learning.
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