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.