Custom-Made Device Manufacturer training
Gain expertise in EU MDR for custom-made orthopaedic implants. Master design controls, risk management, 3D printing validation, labelling, and post-market surveillance to enable engineering teams to produce compliant, traceable, patient-specific devices confidently.

4 to 360 hours flexible workload
valid certificate in your country
What will I learn?
Custom-Made Device Manufacturer Training provides a focused, practical overview of EU MDR requirements for single-patient orthopaedic implants, covering legal definitions, classification, conformity, and documentation. Learn to construct compliant technical files, manage design controls and risks according to ISO 14971, validate additive manufacturing processes, ensure effective labelling and IFU, and conduct robust post-market surveillance and complaint handling.
Elevify advantages
Develop skills
- Mastery of MDR compliance: swiftly map custom implant designs to EU MDR requirements.
- Risk and clinical files: develop ISO 14971 risk assessments, clinical evaluations, and technical documentation.
- Additive manufacturing controls: qualify 3D printing processes, materials, and non-destructive testing.
- Post-market vigilance: implement PMS plans, CAPA processes, and MDR incident reporting.
- Surgeon-centred workflow: align design inputs, labelling, and IFU with surgeons' needs.
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 chance to follow several 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 supplementary videos really help with learning.

Giulio CarloPrompt Engineering Student
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