Custom-Made Device Manufacturer training
This course equips engineering teams with essential knowledge of EU MDR for custom-made orthopedic implants. Participants will master design controls, risk management per ISO 14971, additive manufacturing validation, labelling requirements, and post-market surveillance to produce compliant, traceable, patient-specific devices confidently.

flexible workload of 4 to 360h
valid certificate in your country
What will I learn?
Gain a practical overview of EU MDR requirements for single-patient orthopedic implants, covering legal definitions, classification, conformity assessment, and documentation. Build compliant technical files, manage design controls and risks using ISO 14971, validate 3D printing workflows, ensure proper labelling and instructions for use, 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 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 workloadWhat our students say
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