PRRC (Person Responsible for Regulatory Compliance) Training
Gain mastery of PRRC duties under EU MDR/IVDR through practical checklists, documentation strategies, vigilance processes, and lifecycle controls to guarantee safe medical device release, robust audit evidence, and full regulatory compliance in healthcare products.

4 to 360 hours flexible workload
valid certificate in your country
What will I learn?
Acquire vital skills via PRRC Training to confidently fulfil MDR and IVDR Article 15 requirements. Master interpretation of key regulations, lifecycle management, oversight of clinical and performance evaluations, market release verification, documentation control, and incident plus FSCA handling to keep your organisation compliant, audit-prepared, and in line with European standards.
Elevify advantages
Develop skills
- Apply PRRC release controls including MDR/IVDR checks, sign-offs, and audit-ready records.
- Build regulatory documentation with PRRC files, templates, and traceable evidence.
- Lead risk and vigilance tasks such as incident reporting, FSCA decisions, and CAPA oversight.
- Verify clinical and performance reviews including CER/PER/PMPF and state-of-the-art data.
- Embed PRRC oversight checkpoints throughout the lifecycle from design change to post-market.
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 and simple to use. The diversity of content and complementary videos really help with learning.

André FelipePrompt Engineering Student
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