EU MDR responsible person training
Gain mastery in EU MDR Article 15 and the PRRC role. This course teaches how to review technical files, handle audits, manage risks and clinical evidence, and lead post-market surveillance and vigilance to keep Class IIb and Class I devices safe, compliant, and ready for the market.
from 4 to 360h flexible workload
valid certificate in your country
What will I learn?
EU MDR Responsible Person Training provides practical guidance to confidently handle PRRC duties. You will learn Article 15 requirements, technical documentation, device release controls, risk management, clinical evidence, post-market surveillance, audits, vigilance reporting, change control, and governance to ensure compliance and support safe devices.
Elevify advantages
Develop skills
- Apply Article 15 MDR requirements by defining PRRC duties, qualifications, and making daily decisions confidently.
- Build compliant technical documentation files under MDR and approve device releases with assurance.
- Lead Notified Body audits effectively and address findings using strong CAPA processes.
- Manage risks, design changes, and clinical evidence requirements for Class IIb medical devices.
- Oversee post-market surveillance, vigilance reporting, and PRRC governance to ensure patient safety and reduce liability.
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 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 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 FerresPhotography Student
I like the content and the way videos are presented and transcribed, which speeds up the process!
Luciana AlvarengaNail Design Student
The platform is fast, simple to use. The diversity of content and complementary videos help a lot with learning.
André FelipePrompt Engineering Student
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