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Custom-Made Device Manufacturer training

Custom-Made Device Manufacturer training
from 4 to 360h flexible workload
certificate valid in your country

What will I learn?

This training provides a practical overview of EU MDR for single-patient orthopedic implants, covering legal definitions, classification, conformity, and documentation. Build compliant technical files, manage design controls and ISO 14971 risks, validate 3D printing, ensure labelling and IFU, and handle post-market surveillance and complaints.

Elevify advantages

Develop skills

  • Master EU MDR compliance by quickly mapping custom implant designs to requirements.
  • Develop skills in ISO 14971 risk management, clinical evaluations, and technical documentation.
  • Implement controls for additive manufacturing, including 3D printing qualification, materials, and NDT.
  • Manage post-market surveillance with PMS plans, CAPA, and MDR incident reporting.
  • Optimise surgeon-focused workflows by aligning design inputs, labelling, and IFU.

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 workload.
Workload: between 4 and 360 hours

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 Carlo
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 Ferres
Mariana FerresAluna de Fotografia
Gosto do conteúdo e do modo de apresentação e transcrição de vídeos, o que acelera o processo!
Luciana Alvarenga
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 Carlo
Giulio CarloAluno de Engenharia de Prompt

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