Custom-Made Device Manufacturer training
Master EU MDR for custom-made orthopedic implants. Learn design controls, risk management, 3D printing validation, labeling, and post‑market surveillance so engineering teams can build compliant, traceable, patient-specific devices with confidence.
from 4 to 360h flexible workload
valid certificate in your country
What will I learn?
Custom-made Device Manufacturer Training gives you a focused, practical overview of EU MDR requirements for single-patient orthopedic implants, from legal definitions and classification to conformity and documentation. Learn how to build compliant technical files, manage design controls and risk per ISO 14971, validate additive manufacturing workflows, ensure robust labeling and IFU, and maintain effective post‑market surveillance and complaint handling.
Elevify advantages
Develop skills
- MDR compliance mastery: map custom implant designs to EU MDR requirements fast.
- Risk and clinical files: build ISO 14971 risk, clinical evals, and tech docs.
- Additive manufacturing controls: qualify 3D print, materials, and NDT checks.
- Post-market vigilance: run PMS plans, CAPA, and MDR incident reporting.
- Surgeon-centered workflow: align design inputs, labeling, and IFU with surgeons.
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 classes are perfect. I purchased the one-year package and finally have the opportunity to follow various topics of my interest without needing to change 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 switch 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, simple to use. The diversity of content and complementary videos really help with learning.
André FelipePrompt Engineering Student
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