EU MDR responsible person training
Gain mastery in EU MDR Article 15 and the PRRC role. Learn to review technical documentation, handle audits, manage risks and clinical evidence, and lead post-market surveillance and vigilance to keep your Class IIb and Class I devices safe, compliant, and ready for market.
from 4 to 360h flexible workload
certificate valid 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, 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 solid CAPA evidence.
- Manage MDR risks, design changes, and clinical evidence for Class IIb 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'm grateful 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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