Medical Device Process Validation training
Master medical device process validation for sterile balloon catheters. Learn IQ/OQ/PQ, risk-based FMEA, SPC, and PQ study design to ensure compliant, reproducible bonding processes and audit-ready documentation aligned with FDA, EU MDR, and ISO standards.

from 4 to 360h flexible workload
valid certificate in your country
What will I learn?
This training provides a practical guide to plan and execute IQ/OQ/PQ for medical devices, design robust OQ and PQ studies, use FMEA for CPPs, CQAs, and sampling. It covers bonding fundamentals for sterile balloon catheters, SPC and capability metrics, change control, revalidation, and documentation compliant with EU MDR, ISO 13485, ISO 14971, and FDA rules.
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 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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