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Regulatory Compliance Action Plan Course

Regulatory Compliance Action Plan Course
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 the workload. Choose which chapter to start with. Add or remove chapters. Increase or decrease the course workload.
Workload: between 4 and 360 hours

What our students are saying

I was just promoted to Intelligence Advisor for the Prison System, and the course from Elevify was crucial for me to be the chosen one.
EmersonPolice Investigator
The course was essential to meet my boss's and the company's expectations.
SilviaNurse
Really great course. Lots of valuable information.
WiltonCivil Firefighter

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