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Regulatory Compliance Action Plan Course

Regulatory Compliance Action Plan Course
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.
Workload: between 4 and 360 hours

What our students say

I was just promoted to Intelligence Advisor of the Prison System, and the course from Elevify was crucial for me to be chosen.
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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