Regulatory Compliance Action Plan Course
This course equips professionals with essential skills to build and maintain a compliant Quality Management System for medical devices, focusing on key regulatory requirements and actionable strategies for ongoing compliance and inspection readiness.

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 solid Quality Management System for medical devices in line with 21 CFR Part 820 and EU MDR. You will learn about design controls, risk management, production and supplier monitoring, complaint management, 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
- Develop FDA/EU-compliant QMS: design controls, DHF, risk files in a streamlined workflow.
- Master complaint, CAPA, and vigilance processes for efficient, defensible case management.
- Apply 21 CFR 820 and EU MDR regulations to practical medical device compliance tasks.
- Create efficient audit, training, and document control systems for inspection preparedness.
- Convert 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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