Medical devices – basic course

Medical devices must meet certain requirements to be marketed in Europe. It is important to have a good knowledge of the applicable regulations, including the requirements imposed on both the manufacturer and the product itself. The course is aimed at those who work in the medical technology and/or pharmaceutical field and need knowledge of how the requirements affect your product and the product's life cycle. The course gives you an overview of the regulatory framework and an understanding of how to apply it in practice.

Training objectives

At the end of the course you should have

  • An overview of CE marking and the current regulatory framework for medical devices in the EU, MDR.
  • Knowledge of quality systems and technical documentation
  • Knowledge of the actors and authorities involved
  • Knowledge of risk management systems.
  • Knowledge of applicable regulations, standards and guidelines
Course content and structure
  • Background to the regulatory framework
  • Stakeholders concerned
  • 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

Before the start of the course, you will have access to our preparatory web course (approx. 3h) “Medical Devices Road to Market – an introduction to concepts and requirements” designed by Läkemedelsakademin in consultation with Läkemedelsverket. Read more about “Medical Devices Road to Market” here

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

Time and place

Dates: June 1-2 and the morning of June 4, 2021.

The training will start at around 1 p.m. 08.30 on all days and ending at approx. 17 on days 1 and 2 (June 1-2) and pm. 12 Day 3 (June 4).

Click here for more information and registration.