The course is aimed at importers and/or distributors involved in the regulation of medical devices under the Medical Device Regulation (MDR) or the In Vitro Diagnostic Regulation (IVDR).
Description
The medical devices and in vitro diagnostics industry is subject to the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR). This course provides you with insight and knowledge on, among other things, definitions and the requirements imposed on economic operators, such as verification and market surveillance.
After the training, you should have an increased knowledge of the importer's and distributor's responsibilities regarding e.g. contracts, document control, complaint handling and traceability.
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 & IVDR For distributors & importers of Medtech & in vitro diagnostics |
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 & IVDR | ||
| Principles of MDR & IVDR |
