PRRC (Person Responsible for Regulatory Compliance) Training
Gain mastery in PRRC responsibilities under EU MDR/IVDR regulations. Acquire practical checklists, documentation skills, vigilance practices, and lifecycle controls to ensure 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?
This PRRC Training equips you with vital skills to confidently fulfil MDR and IVDR Article 15 requirements. Master interpreting key regulations, managing lifecycle duties, supervising clinical and performance evaluations, verifying market releases, controlling documentation, and managing incidents plus FSCA to keep your organisation 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 like incident reporting, FSCA decisions, and CAPA oversight.
- Verify clinical and performance reviews with CER/PER/PMPF and state-of-the-art data.
- Embed PRRC checkpoints for lifecycle oversight 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
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