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 in line with FDA, EU MDR, and ISO standards.

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 workload. Choose which chapter to start with. Add or remove chapters. Increase or decrease the course workload.What our students say
Your classes are perfect. I got the one-year package and finally have the chance to follow several topics I'm interested in without having to switch platforms... I appreciate everything you do, I've already recommended you to others...

Giulio CarloDigital Marketing Student
I like how the lessons get straight to the point and how I can switch chapters and skip content I don't need.

Mariana FerresPhotography Student
I like the content and the way the videos are presented and transcribed, which speeds up the process!

Luciana AlvarengaNail Design Student
The platform is fast and easy to use. The variety of content and the extra videos really help with learning.

Giulio CarloPrompt Engineering Student
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