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

4 to 360h flexible workload
certificate valid in your country
What will I learn?
Acquire vital skills via PRRC Training to confidently fulfill MDR and IVDR Article 15 requirements. Master interpreting regulations, handling lifecycle duties, supervising clinical and performance evaluations, approving market releases, managing documentation, and addressing incidents plus FSCA to keep your organization compliant, audit-prepared, and in line with European standards.
Elevify advantages
Develop skills
- Apply PRRC release controls with MDR/IVDR checks, sign-offs, and audit-ready records.
- Build regulatory documentation including 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 using CER/PER/PMPF and state-of-the-art data.
- Embed PRRC oversight checkpoints throughout the lifecycle from design changes 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 are saying
Your classes are perfect. I purchased the one-year package and finally have the opportunity to follow various topics of interest without needing to switch 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 presentation style 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 really help with learning.

André FelipePrompt Engineering Student
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