EU MDR responsible person training
Gain expertise in EU MDR Article 15 and the PRRC role. Master reviewing technical documentation, handling audits, managing risks and clinical evidence, and leading post-market surveillance and vigilance to keep Class IIb and Class I devices safe, compliant, and ready for the market.
flexible workload of 4 to 360h
valid certificate in your country
What will I learn?
EU MDR Responsible Person Training offers practical guidance to fulfil PRRC duties confidently. It covers Article 15 obligations, technical documentation, device release processes, risk management, clinical evidence, post-market surveillance, audits, vigilance reporting, change control, and governance for ensuring device compliance and safety.
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 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 change chapters and skip content that I don't need.
Mariana FerresPhotography Student
I like the content and the way of presentation and video transcription, 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 in learning.
André FelipePrompt Engineering Student
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