Custom-Made Device Manufacturer training
Master EU MDR for custom-made orthopedic implants. Learn design controls, risk management, 3D printing validation, labeling, and post-market surveillance so engineering teams can build compliant, traceable, patient-specific devices with confidence.
from 4 to 360h flexible workload
valid certificate in your country
What will I learn?
Custom-made Device Manufacturer Training gives you a focused, practical overview of EU MDR requirements for single-patient orthopedic implants, from legal definitions and classification to conformity and documentation. Learn how to build compliant technical files, manage design controls and risk per ISO 14971, validate additive manufacturing workflows, ensure robust labeling and IFU, and maintain effective post-market surveillance and complaint handling.
Elevify advantages
Develop skills
- MDR compliance mastery: map custom implant designs to EU MDR requirements fast.
- Risk and clinical files: build ISO 14971 risk, clinical evals, and tech docs.
- Additive manufacturing controls: qualify 3D print, materials, and NDT checks.
- Post-market vigilance: run PMS plans, CAPA, and MDR incident reporting.
- Surgeon-centered workflow: align design inputs, labeling, and IFU with surgeons.
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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