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Medical Device Process Validation training

Medical Device Process Validation training
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.
Workload: between 4 and 360 hours

What our students say

Your lessons are perfect. I purchased the one-year package and finally have the opportunity to follow various topics of my interest without needing to change platforms... I thank you for everything you do, I've already recommended you to other people...
Giulio Carlo
Giulio CarloDigital Marketing Student
I like how the lessons are straight to the point and how I can change chapters and skip content I don't need.
Mariana Ferres
Mariana FerresPhotography Student
I like the content and the way videos are presented and transcribed, which speeds up the process!
Luciana Alvarenga
Luciana AlvarengaNail Design Student
The platform is fast, simple to use. The diversity of content and complementary videos really help with learning.
André Felipe
André FelipePrompt Engineering Student

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