Regulatory Compliance Action Plan Course
This course equips professionals with essential skills to build 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, complaint handling, CAPA processes, and action planning to ensure ongoing inspection readiness and 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 develop, 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 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 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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