Custom-Made Device Manufacturer training
This training equips you with essential knowledge on EU MDR for custom-made orthopedic implants. It covers design controls, risk management using ISO 14971, validation of additive manufacturing, proper labelling and IFU, plus post-market surveillance to ensure compliant patient-specific devices.

flexible workload from 4 to 360h
valid certificate in your country
What will I learn?
Gain practical insights into EU MDR for single-patient orthopedic implants, covering legal definitions, classification, conformity assessment, and documentation. Master building 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 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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