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

4 to 360 hours flexible workload
valid certificate in your country
What will I learn?
This training provides a practical overview of EU MDR for single-patient orthopedic implants, including legal definitions, classification, conformity assessment, and documentation. Build compliant technical files, manage design controls and ISO 14971 risks, validate 3D printing processes, ensure proper labelling and IFU, and handle post-market surveillance and complaints effectively.
Elevify advantages
Develop skills
- Master EU MDR compliance by quickly mapping custom implant designs to 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 MDR incident reporting.
- Design surgeon-focused workflows aligning inputs, labelling, 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 say
Your classes are perfect. I got the one-year package and finally have the chance to follow a range of topics I'm interested in without having to switch platforms... thank you for everything you do, I've already recommended you to others...

Giulio CarloDigital Marketing Student
I like how the lessons get 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 the videos are presented and transcribed, which speeds up the process!

Luciana AlvarengaNail Design Student
The platform is fast and easy to use. The variety of content and the extra videos really help with learning.

Giulio CarloPrompt Engineering Student
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