PRRC (Person Responsible for Regulatory Compliance) Training
Master PRRC duties under EU MDR/IVDR. Gain practical checklists, documentation skills, vigilance know-how, and lifecycle controls to ensure safe device release, solid audit evidence, and full regulatory compliance for healthcare products. Minimum 50 characters.

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 handle MDR and IVDR Article 15 duties. Master interpreting key regulations, managing lifecycle tasks, overseeing clinical and performance evaluations, verifying market releases, controlling documentation, and managing incidents plus FSCA to keep your organization compliant, audit-ready, and in line with European standards. Minimum 50 characters.
Elevify advantages
Develop skills
- Apply PRRC release controls with MDR/IVDR checks, sign-offs, and audit-ready records.
- Build solid 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 from design changes right through 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
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