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 under FDA 21 CFR Part 820 and EU MDR regulations, focusing on practical implementation of key processes to ensure inspection readiness and regulatory adherence.
flexible workload of 4 to 360h
valid certificate in your country
What will I learn?
The Regulatory Compliance Action Plan Course provides practical tools to build, assess, and enhance a strong QMS for medical devices as per 21 CFR Part 820 and EU MDR. You will learn design controls, risk management, production and supplier oversight, complaint handling, CAPA, document control, audits, and action planning to address gaps swiftly and remain prepared for inspections with clear, defensible records and processes.
Elevify advantages
Develop skills
- Build FDA/EU-compliant QMS: design controls, DHF, risk files in a streamlined workflow.
- Master complaint, CAPA, and vigilance processes for quick, defensible case management.
- Map and implement 21 CFR 820 & EU MDR requirements to practical device compliance tasks.
- Design 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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