Regulatory Compliance Action Plan Course
This course equips professionals with essential skills to develop and maintain a compliant Quality Management System (QMS) for medical devices, aligning with FDA 21 CFR Part 820 and EU MDR regulations. Participants will gain practical expertise in key areas such as design controls, risk management, CAPA processes, and audit preparation to ensure inspection readiness and effective regulatory compliance.
from 4 to 360h flexible workload
valid certificate in your country
What will I learn?
The Regulatory Compliance Action Plan Course provides practical tools to build, assess, and improve a robust QMS for medical devices under 21 CFR Part 820 and EU MDR. Learn design controls, risk management, production and supplier oversight, complaint handling, CAPA, document control, audits, and action planning so you can close gaps quickly and stay inspection ready with clear, defensible records and processes.
Elevify advantages
Develop skills
- Build FDA/EU-ready QMS: design controls, DHF, risk files in a compact workflow.
- Master complaint, CAPA, and vigilance steps for fast, defensible case handling.
- Map and apply 21 CFR 820 & EU MDR rules to real-world device compliance tasks.
- Design lean audit, training, and document control systems for inspection readiness.
- Turn audit findings into a clear, risk-based Regulatory Compliance Action Plan.
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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