PRRC (Person Responsible for Regulatory Compliance) Training
Gain mastery in PRRC duties under EU MDR/IVDR regulations. Develop practical skills in checklists, documentation management, vigilance processes, and lifecycle controls to guarantee safe medical device releases, robust audit trails, and full regulatory compliance for healthcare products.
from 4 to 360h flexible workload
valid certificate in your country
What will I learn?
Acquire vital skills through PRRC Training to confidently fulfill MDR and IVDR Article 15 requirements. Master interpreting key regulations, handling lifecycle duties, supervising clinical and performance evaluations, confirming market releases, managing documentation, and addressing incidents plus FSCA to keep your organization compliant, prepared for audits, 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 like 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 across the lifecycle from design changes to post-market.
Suggested summary
Before starting, you can change the chapters and 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!
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The platform is fast, simple to use. The diversity of content and complementary videos help a lot with learning.
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