PRRC (Person Responsible for Regulatory Compliance) Training
Gain mastery in PRRC duties under EU MDR/IVDR regulations. Acquire practical checklists, documentation skills, vigilance practices, and lifecycle controls to guarantee safe medical device release, robust audit evidence, 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 regulations, handling lifecycle duties, supervising clinical and performance evaluations, confirming 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 using 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 with 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 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.
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The platform is fast, simple to use. The diversity of content and complementary videos really help with learning.
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