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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 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.
Workload: between 4 and 360 hours

What our students say

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EmersonPolice Investigator
The course was essential to meet the expectations of my boss and the company I work for.
SilviaNurse
Very great course. Lots of rich information.
WiltonCivil Firefighter

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