The course is aimed at those who work with the manufacture of medical devices and want to understand the requirements for medical devices in Europe and want to gain practical knowledge to meet these requirements. The course is also held in collaboration with Swedish Medtech.
The medical device industry is subject to the Medical Device Regulation (MDR) and all medical devices placed on the European market must be CE marked as proof that the product complies with applicable legal requirements.
This course gives you an overview of the Medical Device Regulation (MDR), the CE marking process and insight into quality management systems for medical devices (according to ISO 13485).
After the training, you should have gained insight and knowledge of MDR to help your organization understand and meet the requirements for CE marking. During this training, we focus on the requirements imposed on you as a manufacturer of medical devices. In addition, you will get an overall picture of the status of the EU Commission's work and implementation of the regulations.