EU MDR responsible person training
Gain mastery in EU MDR Article 15 and the PRRC role. This course teaches how to review technical documentation, handle audits, manage risk and clinical evidence, and lead post-market surveillance and vigilance activities. Ensure your organisation's Class IIb and Class I devices remain 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 clear, practical guidance to confidently perform PRRC duties. Master Article 15 requirements, technical documentation, device release controls, risk management, clinical evidence, and post-market surveillance. Learn to manage audits, vigilance reporting, change control, and governance to ensure compliance and support safe, effective medical devices.
Elevify advantages
Develop skills
- Apply Article 15 MDR requirements by defining PRRC duties, qualifications, and making daily decisions.
- Build compliant technical documentation files under MDR and confidently sign off on device releases.
- Lead Notified Body audits effectively and respond to findings using strong CAPA evidence.
- Manage risks, design changes, and clinical evidence requirements for Class IIb medical devices.
- Oversee post-market surveillance, vigilance reporting, and PRRC governance to safeguard patients and reduce liability.
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.What our students say
Your lessons are perfect. I purchased the one-year package and finally have the opportunity to follow various topics of 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 really help with learning.
André FelipePrompt Engineering Student
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