Why Should You Attend:

Many medical devices are controlled by software that governs key aspects of the user interface, and performs key safety functions. Users often do not realize the extent to which software determines many of the key functional and performance characteristics of the system until something goes wrong. Unfortunately, in some cases, the software does “go wrong” and compromises performance reliability and patient safety. Because software is inevitably complex, abstract, and intangible, design errors can be difficult to detect. The occurrence of a software error should be a highly unusual event.

Areas Covered in the Seminar:

- FDA Quality System Requirements.
- Principles of software reliability.
- Principles of software safety.
- Software requirements analysis methods.
- Software Failure Mode and Effects Analysis.
- Software Hazard Analysis.
- Software structure for reliability and safety.
- Software architecture for reliability and safety.
- Manual code reviews.