Training Features

A Practical Foundation for Medical Device and IVD Professionals

Build a solid foundation in the EU MDR and IVDR and confidently navigate the regulatory landscape for medical devices and IVDs.
Format

E-Learning

Level

Beginner

Trainer

René Schings

Exam

Exam and certificate included

Duration

1 hour
8 modules

Price

€ 195 or equivalent currency

Course Overview & Description

The Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR) have fundamentally changed how medical devices are developed, certified and maintained within the European market. Understanding these regulations is no longer only important for regulatory professionals, it is essential for anyone involved in product development, quality, clinical affairs, manufacturing or commercialization.

This introductory e-learning gives you a clear, practical overview of the European regulatory framework. Through six engaging modules, you will discover how the MDR and IVDR support patient safety, how products achieve CE marking, why clinical evidence and risk management are central to compliance, and how manufacturers maintain compliance throughout the product lifecycle.
What You Will Learn
Who Should Attend?
What is Included?
Course Details
Develop a solid understanding of the European regulatory framework for medical devices and in vitro diagnostic medical devices, and discover how the MDR and IVDR support safe, compliant, and successful market access throughout the product lifecycle.

After completing this e-learning, you will be able to:
  • Understand the purpose and scope of the MDR and IVDR, including the key differences between the two regulations.
  • Explain how devices are classified and brought to market, including the role of conformity assessment, CE marking, and EUDAMED registration.
  • Recognize the responsibilities of key stakeholders, including manufacturers, notified bodies, competent authorities, and other Economic Operators.
  • Describe the importance of clinical evidence, risk management, and post market surveillance in achieving and maintaining regulatory compliance.
  • Appreciate the strategic business impact of regulatory compliance, from product development and market access to long term commercial success and future regulatory developments.
What is included in this e-learning?
  • Access to the Qserve Learn Training Portal
  • A training certificate upon completion of the training.
Access to any mentioned guidances or ISO standards that are not publicly available is not included in this e-learning.
  • Duration: Approx. 1 hour.
  • Format: Self-paced e-learning (video, interactive content, and quizzes).
This e-learning is suitable for:
  • Professionals who are new to the medical device or IVD industry.
  • Regulatory Affairs professionals starting their MDR or IVDR journey.
  • Quality Assurance professionals.
  • R&D and Product Development teams.
  • Clinical Affairs professionals.
  • Project managers.
  • Marketing and commercial teams working within MedTech.
  • Anyone seeking a high level understanding of the European regulatory framework.

Comprehensive Regulatory Expertise

Gain recognized certification, advance your regulatory career, and learn at your own pace with a flexible learning schedule designed for medical device professionals.
Upon successful completion of the program, participants receive a recognized certification, boosting their career prospects and demonstrating their expertise to employers and clients.

Certification and Career Advancement

We offer a flexible learning schedule, allowing professionals to balance their training with their busy work and personal lives, ensuring accessibility to a wide range of learners.

Flexible Learning Schedule

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.
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