Custom-Made Device Manufacturer training
Gain expertise in EU MDR for custom-made orthopedic implants. Master design controls, risk management per ISO 14971, additive manufacturing validation, labelling, IFU, and post-market surveillance to produce compliant, traceable patient-specific devices confidently.

from 4 to 360h flexible workload
certificate valid in your country
What will I learn?
This training provides a practical overview of EU MDR for single-patient orthopedic implants, covering legal definitions, classification, conformity, and documentation. Build compliant technical files, manage design controls and ISO 14971 risks, validate 3D printing, ensure labelling and IFU, and handle post-market surveillance and complaints.
Elevify advantages
Develop skills
- Master EU MDR compliance by quickly mapping custom implant designs to requirements.
- Develop skills in ISO 14971 risk management, 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, and MDR incident reporting.
- Optimise surgeon-focused workflows by aligning design inputs, labelling, and IFU.
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, simple to use. The diversity of content and complementary videos really help with learning.

André FelipePrompt Engineering Student
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