Medical Devices - Introduction

About the Course

Would you like a clear overview of the regulations governing medical devices and learn how they impact your product throughout its lifecycle? This course provides practical tools and insights on CE marking, quality systems, and risk management, along with guidance on how to apply them directly in your work. The course is given in Swedish.

Who Should Attend?

The course is designed for professionals in the medical device and/or pharmaceutical fields who need knowledge on how regulatory requirements affect their product and its lifecycle. During the course, you will gain an overview of the governing regulations and practical understanding of their application. The target audience includes manufacturers, authorized representatives, distributors, importers, contract manufacturers, component manufacturers, and consultants.

Learning Objectives

After the course, you will have gained:

• An overview of CE marking and applicable EU regulations for medical devices (MDR)
• Knowledge of quality systems and technical documentation
• An understanding of the roles of involved actors and authorities
• Insight into risk management systems
• Knowledge of applicable regulations, standards, and guidelines

Course Content

• Background to the regulatory framework
• Involved actors
• Regulatory strategy
• Qualification and classification
• Standards and guidance documents
• Development process
• Risk management systems, quality systems, and technical documentation
• Clinical evaluation and clinical trials of medical devices
• Post-market surveillance/vigilance
• Practical exercises and group work
• Knowledge test

The course combines theory with practical exercises/group work, questions, and discussions.