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

from 4 to 360h flexible workload
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. Master building compliant technical files, managing design controls and risks under ISO 14971, validating 3D printing workflows, ensuring proper labelling and instructions for use, and handling 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 workload. Choose which chapter to start with. Add or remove chapters. Increase or decrease the course workload.What our students say
As suas aulas são perfeitas. Adquiri o pacote de um ano e, finalmente, tenho a oportunidade de acompanhar diversos temas do meu interesse sem precisar mudar de plataforma... agradeço por tudo o que fazem, já recomendei vocês a outras pessoas...

Giulio CarloAluno de Marketing Digital
Eu gosto de como as lições são direto ao ponto e como eu consigo alterar capítulos e pular conteúdos que não preciso.

Mariana FerresAluna de Fotografia
Gosto do conteúdo e do modo de apresentação e transcrição de vídeos, o que acelera o processo!

Luciana AlvarengaAluna de Design de Unhas
A plataforma é rápida, simples de usar. A diversidade de conteúdo e os vídeos complementares ajudam muito no aprendizado.

Giulio CarloAluno de Engenharia de Prompt
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