The course is aimed at those who want to know more about Regulatory Affairs or need to update their knowledge in the field. You need to know how to integrate regulatory issues into your global strategy with a focus on Europe and the US.
The medical device industry in Europe is subject to the Medical Device Regulation (MDR), but if you also want your product in other markets such as the US, you need to comply with US regulatory requirements.
This course gives you an overview of the current regulatory framework in Europe and the US. Review of what changes are seen in the long term, what you as a medical device manufacturer should plan for and how you can organize your global strategies. After the training, you should have gained an insight into the various opportunities available to gain access to markets in Europe and the US. Knowledge of how to plan for broad market access during the development phase of a product and throughout the product's life cycle.
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.
|Instructor-led course can be done on request|
Dates for planned courses can be found in the calendar or on the right side of this page.
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 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 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.
|Essentials of Regulatory Affairs|
|Principles of Regulatory Affairs|