PRRC (person Responsible for Regulatory Compliance) Training
Master PRRC responsibilities under EU MDR/IVDR. Learn practical checklists, documentation, vigilance, and lifecycle controls to ensure safe device release, strong audit evidence, and regulatory compliance for healthcare products.

from 4 to 360h flexible workload
valid certificate in your country
What will I learn?
This PRRC Training gives you the essential skills to meet MDR and IVDR Article 15 obligations with confidence. Learn how to interpret key regulations, manage lifecycle responsibilities, oversee clinical and performance evaluations, verify release to market, control documentation, and handle incidents and FSCA so your organization stays compliant, audit-ready, and aligned with European regulatory expectations.
Elevify advantages
Develop skills
- PRRC release controls: Apply MDR/IVDR checks, sign-offs, and audit-ready records.
- Regulatory documentation: Build PRRC files, templates, and traceable evidence.
- Risk and vigilance: Lead incident reporting, FSCA decisions, and CAPA oversight.
- Clinical and performance review: Verify CER/PER/PMPF and state-of-the-art data.
- Lifecycle oversight: Embed PRRC checkpoints from design change 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 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 switch 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.

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