Regulatory Compliance Action Plan Course
This course equips professionals with essential skills to develop and implement a robust Quality Management System (QMS) for medical devices, ensuring compliance with 21 CFR Part 820 and EU MDR through practical action planning and process optimization.
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 construct, evaluate, and enhance a strong QMS for medical devices in line with 21 CFR Part 820 and EU MDR. You will learn about design controls, risk management, production and supplier oversight, complaint handling, CAPA, document control, audits, and action planning to address gaps swiftly and maintain inspection readiness through 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 workload. Choose which chapter to start with. Add or remove chapters. Increase or decrease the course workloadWhat our students say
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