Training Features

Understanding EU MDR and IVDR Essential Knowledge for Non-Regulatory Staff

A 2-hour e-learning designed for support staff and non-consultant functions in the MedTech industry.
Format

E-Learning

Level

Basic

Trainer

René Schings

Exam

Exam and certificate included

Duration

2 hours
8 modules

Price

€ 295 or equivalent currency

Compliance is Everyone's Job: A Practical Introduction to MDR & IVDR

The new EU regulations for medical devices (MDR) and diagnostics (IVDR) have fundamentally changed our industry. But these rules aren't just for regulatory consultants.

If you work in marketing, finance, logistics, HR, or any administrative role, your work is a vital link in the compliance chain. A simple check in the warehouse or a correct address on an invoice is now a key part of our legal duty.

This engaging 2-hour course is designed specifically for you. It skips the deep technical jargon and focuses on the "what," "why," and "so what?"—giving you the foundation you need to understand the world you work in and see how your role makes a difference.
What You Will Learn
Who Should Attend?
What is Included?
Course Details
  • Understand the "magic question" to identify a medical device (MDR) vs. a diagnostic (IVDR).
  • Explain why these new, stricter rules were created (and why they impact us all).
  • Recognize the "chain of responsibility" and the four "Economic Operators" (Manufacturer, Importer, Distributor, AR).
  • See how your specific job is an essential part of regulatory compliance.
  • Feel confident in your understanding of the MedTech industry and its mission.
What is included in this e-learning?
  • Access to the Qserve Learn Training Portal
  • A training certificate upon completion of the training.
  • Duration: Approx. 2 Hours
  • Format: Self-paced e-learning (video, interactive content, and quizzes).
This training is ideal for all non-regulatory and non-consultant staff in a MedTech company, including:
  • Logistics, Supply Chain, and Warehouse Teams
  • Finance, Accounting, and Purchasing Departments
  • Marketing, Sales Support, and Communications Teams
  • Human Resources, IT, and Administrative Staff
  • Anyone new to the medical device industry.
Modules

Explore the training modules available in this course

Meet the Trainer

René Schings

René, with over 20 years of management experience in Quality Management, Research & Development, and more, serves as a lead auditor at Qserve, specializing in ISO audits, and brings expertise in building QMS for start-ups, managing complex change projects, and overseeing multi-site, multi-cultural teams, having previously held senior positions in the Medical Device and Consumer Electronics industries.
Write your awesome label here.