The course is aimed at those who work with medical devices and software and need an overview of the requirements introduced for software with regard to the Medical Device Regulation (MDR).
Description
The medical device industry is subject to the Medical Device Regulation (MDR) and in order to sell medical devices, the manufacturer must CE mark according to these requirements.
This course gives you an overview of the requirements introduced for software with regard to MDR. We look at the definition of Software as a Medical Device (SaMD) and the application of a medical device software - throughout the entire life cycle, focusing on ease of use, a risk-based approach, software development, as well as what software documentation should be included in the technical file.
At the end of the course, you should have an overall view of the software development process according to the MDR framework. You will be able to use your new knowledge in current and future software development projects. You will know what is required to develop a software process.
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.
| Software for medical devices | ½ 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 Medtech Software & MDR | ||
| Principles of Medtech Software & MDR |
