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Custom-Made Device Manufacturer training

Custom-Made Device Manufacturer training
flexible workload from 4 to 360h
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 workload. Choose which chapter to start with. Add or remove chapters. Increase or decrease the course workload.
Workload: between 4 and 360 hours

What our students say

Your classes are perfect. I purchased the one-year package and finally have the chance to follow several topics I'm interested in without needing to switch platforms... I appreciate everything you do, I've already recommended you to others...
Giulio Carlo
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 Ferres
Mariana FerresPhotography Student
I like the content and the way the videos are presented and transcribed, which speeds up the process!
Luciana Alvarenga
Luciana AlvarengaNail Design Student
The platform is fast and easy to use. The variety of content and the supplementary videos really help with learning.
Giulio Carlo
Giulio CarloPrompt Engineering Student

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