Custom-Made Device Manufacturer training
This training provides a practical guide to EU MDR compliance for custom orthopedic implants, covering design controls, ISO 14971 risk management, additive manufacturing validation, labeling requirements, and post-market surveillance to enable confident production of patient-specific devices.
from 4 to 360h flexible workload
valid certificate in your country
What will I learn?
Gain practical knowledge of EU MDR rules for single-patient orthopedic implants, including legal definitions, classification, conformity assessment, and documentation. Build compliant technical files, manage design controls and risks using ISO 14971, validate 3D printing processes, ensure proper labeling and instructions for use, and handle post-market surveillance and complaints effectively.
Elevify advantages
Develop skills
- Master EU MDR compliance by quickly mapping custom orthopedic implant designs to requirements.
- Develop skills in creating 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, labeling, 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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