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
certificate valid in your country
What will I learn?
This PRRC Training equips you with vital skills to confidently fulfil MDR and IVDR Article 15 requirements. Master interpreting key regulations, handling lifecycle duties, supervising clinical and performance evaluations, confirming market release, managing documentation, and addressing incidents and FSCA to keep your organisation compliant, audit-prepared, and in line with European standards.
Elevify advantages
Develop skills
- Implement PRRC release controls using MDR/IVDR checks, sign-offs, and audit-ready records.
- Develop regulatory documentation including PRRC files, templates, and traceable evidence.
- Manage risk and vigilance by leading incident reporting, FSCA decisions, and CAPA oversight.
- Conduct clinical and performance reviews to verify CER/PER/PMPF and state-of-the-art data.
- Oversee product lifecycle with PRRC checkpoints from design changes to post-market surveillance.
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.
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