Custom-Made Device Manufacturer training
This training equips engineering teams with essential knowledge on EU MDR for custom-made orthopedic implants. It covers design controls, risk management per ISO 14971, validation of additive manufacturing, proper labelling and IFU, plus 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 practical insights into 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 ISO 14971 risks, validating 3D printing workflows, ensuring effective labelling and IFU, and handling post-market surveillance and complaints.
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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