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Custom-Made Device Manufacturer training

Custom-Made Device Manufacturer training
from 4 to 360h flexible workload
valid certificate in your country

What will I learn?

Gain practical insights into EU MDR requirements for single-patient orthopedic implants, covering legal definitions, classification, conformity assessment, and documentation. Master building compliant technical files, managing design controls and ISO 14971 risks, validating 3D printing workflows, ensuring effective labelling and IFU, and handling post-market surveillance and complaints.

Elevify advantages

Develop skills

  • Master EU MDR compliance by quickly mapping custom implant designs to requirements.
  • Develop skills in building ISO 14971 risk files, clinical evaluations, and technical documentation.
  • Gain expertise in qualifying 3D printing processes, materials, and non-destructive testing.
  • Learn to implement post-market surveillance plans, CAPA processes, and incident reporting.
  • Align design inputs, labelling, and instructions for use with surgeon needs.

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 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 Carlo
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 Ferres
Mariana FerresPhotography Student
I like the content and the way videos are presented and transcribed, which speeds up the process!
Luciana Alvarenga
Luciana AlvarengaNail Design Student
The platform is fast, simple to use. The diversity of content and complementary videos help a lot with learning.
André Felipe
André FelipePrompt Engineering Student

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