The aim of functional safety is to design medical devices in such a way that any probable technical defect is detected in advance and does not pose a hazard. In this course you will learn about the standards applicable to functional safety, understand the basic principles of functional safety, and how to apply that knowledge to the development of your medical devices.
Building on this, we will provide you with knowledge on the subject of computer safety and automatic self-tests of computer components. You will learn about the challenges of selecting and implementing the right techniques for the respective application.
- You will acquire knowledge of the standards for functional safety of medical devices.
- You will achieve increased product safety within the development processes of your medical devices.
- You avoid risks to patients.
- You develop according to the state of the art and reduce liability risks.
THIS COURSE IS SPECIALLY DESIGNED FOR:
- Manufacturers of active medical devices
- Developers (hardware and software) of all medical devices
- Employees and managers from research and development
- Quality managers, regulatory affairs
- Basics of functional safety
- Legal requirements, standards
- Failure modes
- History and concept of functional safety
- Fault assumptions and exclusions
- Safe architectures
- Common-mode faults
- PEMS and IEC 62304
- Microcontroller self-tests
- Software tests
- Test of analog components
- User Interface
- Visual and audible alarm
- Software and software update
- Remote control of medical devices, telemedicine
- Final Exam