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Medical Device Process Validation training

Medical Device Process Validation training
from 4 to 360h flexible workload
certificate valid in your country

What will I learn?

Medical Device Process Validation Training gives you a clear, practical roadmap to plan and execute IQ/OQ/PQ, design robust OQ and PQ studies, and apply FMEA to define CPPs, CQAs, and sampling plans. Learn bonding process fundamentals for sterile balloon catheters, apply SPC and capability metrics, manage change control and revalidation triggers, and align documentation with EU MDR, ISO 13485, ISO 14971, and FDA expectations.

Elevify advantages

Develop skills

  • Risk-based FMEA planning: build CPPs, CQAs, and smart revalidation triggers.
  • IQ/OQ/PQ execution: plan, document, and defend medical device validations fast.
  • OQ/PQ statistics: design studies, set acceptance criteria, and prove capability.
  • Process monitoring: apply SPC, trending, and revalidation rules to stay compliant.
  • EU/FDA alignment: meet ISO 13485, ISO 14971, MDR, and 21 CFR 820 in practice.

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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