Medical device software is a market category that is growing with the use of apps or medical devices with integrated software. A major aspect of medical device software is identifying and minimizing cybersecurity risks.
In the course "Software for Medical Devices" we give you an overview of the requirements introduced for software with regard to MDR. Do you know what classifies a medical device software and what documentation you need to produce? The medical device industry is subject to the Medical Device Regulation (MDR) and in order to sell medical devices, the manufacturer CE marks according to these requirements. Let's take a closer look at the definition for Software as a Medical Device versus Medical Device Software. We'll help you get your facts straight today, to be ready tomorrow.
The course also covers the application of medical device software - throughout the lifecycle, focusing on ease of use, a risk-based approach, software development, and what software documentation should be covered in the technical file. After the course, you will have a holistic 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 and you will know what it takes to develop a software process.
From the content
- Briefly about the applicable rules and regulations
- Medical Device Regulations with regard to software (Medical Device Software)
- Software documentation in a technical file (Verification & Validation)
- Introduction to Risk Management & Ease of Use
- System life cycle of an MDSW
The course is suitable for those who
- Are new to the industry and need to get a clear picture of the laws and regulations that apply to Medical Device Software.
- Have plans to develop an MDSW and want clarity on procedures/documentation and classification.
- Want to prepare you for future roles in Regulatory Affairs and support a team developing an MDSW.
Prerequisites
In order to take the course, you need to have a basic understanding of the regulations. We recommend that you have attended some of our introductory courses to the MDR before this one. If you have not attended them but have similar experience, please contact us and we will be happy to advise and guide you. The course mixes practical exercises and discussions with theory sessions. Welcome, please register via the link below.
