EU MDR responsible person training
Gain mastery in EU MDR Article 15 and the PRRC role. This course teaches how to review technical documentation, manage audits, oversee risk and clinical evidence, and lead post-market surveillance and vigilance to ensure Class IIb and Class I devices remain safe, compliant, and ready for 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 perform PRRC duties confidently. It covers 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 daily decisions.
- Build compliant MDR technical files and confidently sign off on device releases.
- Lead Notified Body audits and respond effectively to findings with strong CAPA evidence.
- Manage MDR risk management, design changes, and clinical evidence for Class IIb devices.
- Oversee post-market surveillance, vigilance reporting, and PRRC governance to protect 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 classes 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 switch 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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