Explore the frontiers of medical software development!
During the training you will get an overview of how MDSW, SaMD and SiMD are related and which regulations they are subject to. Theoretical aspects, such as intended purpose, classification and detailed design in software development, are mixed with practical case studies and exercises. We follow a medical device through the entire product development process, and you will have the opportunity to practice by yourself or in groups on different examples, including your own product if you wish.
You will also have the opportunity to discuss current issues in cybersecurity and its impact on medical devices. We will discuss different AI models, such as supervised, unsupervised and reinforced learning, and link these learning models to regulations and product development.
CONTENT
- What is Medical Device software and its classification
- Review of the concepts of MDSW, SaMD and SiMD
- Medical software vs. 'Health Software'
- Distinguishing between "Fitness Tech" and medical devices
- Regulations, Guideline & standard (e.g. MDR, IVDR, MDCG, IEC, ISO, GSPR)
- The development process of MDSW according to IEC 62304
- Cybersecurity aspects within the MDSW
- The role of AI in medical software development
- Practical exercises and case studies
TARGET GROUP
The course is intended for QA, RA and R&D professionals in the medical device sector, including those working in eHealth. It is also suitable for those developing MDSW, SaMD, or SiMD. For those who want insights into regulations and how new technologies affect product development.
SKILLS
To benefit from the training, you need to have a basic understanding of MDR, the medical device regulations. We recommend that you first attend one of our basic MDR training courses.
