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.
Description
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.
Instructor-led course
Our instructor-led courses are carried out by our most sought-after consultants as educators. Classroom days are complemented by online training, so you can still meet others with similar challenges even when you are unable to travel or be away from work.
If instructor-led course dates are missing for the course you want to attend or if you want to customize a course for your specific needs, you can contact us and together we can find the best solution for you.
Most of the instructor-led courses are organized with our partners
Läkemedelsakademin (The Swedish Academy of Pharmaceutical Sciences), Swedish Medtech & Swedish Labtech.
| MDR For manufacturers of medical devices |
1 day |
Dates for planned courses can be found in the calendar or on the right side of this page.
Interactive e-learning
Essentials of
Essentials is for those who want to get a brief overview of a topic without in-depth training and tests. Our Essentials trainings are on average about 15 minutes long and do not include tests/certificates.
Principles of
Principles is for those who want a basic course in a subject. Provides a good foundation for learning more and includes the "Essentials of".
Advances of
Advances of is for those who want to gain an in-depth understanding of a topic. Here we recommend that you already have basic knowledge in the area or have completed our "Principles of" training in the area.
During planning
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| Essentials of MDR | ||
| Principles of MDR |
