Custom-Made Device Manufacturer training
This course provides a practical overview of EU MDR requirements for custom-made orthopedic implants. Participants will learn to build compliant technical files, manage design controls and risks per ISO 14971, validate additive manufacturing, ensure proper labelling and IFU, and handle post-market surveillance and complaints effectively.

flexible workload of 4 to 360h
valid certificate in your country
What will I learn?
Gain a focused, practical understanding of EU MDR for single-patient orthopedic implants, covering legal definitions, classification, conformity assessment, and documentation. Master building compliant technical files, design controls, ISO 14971 risk management, additive manufacturing validation, labelling, IFU, post-market surveillance, and complaint handling.
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 the workload. Choose which chapter to start with. Add or remove chapters. Increase or decrease the course workload.What our students say
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