3hr Virtual Seminar on Designing Medical Device Software to Prevent Product Recalls (Medical Devices Trai)
|Event Date/Time: Jul 11, 2011||End Date/Time: Jul 11, 2011|
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 â€œgo wrongâ€ 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.
The trend of recalls of products containing software is up. Historically, software safety has been focused on the software development process and system-level testing.. Having skilled engineers and a rigorous software development process, as required by the FDA is important to help to minimize errors. However, assessing the software development process provides only a partial reliability of the software, and system-level testing that would comprehensively test the software is currently beyond the state of the art except for a very simple system. How we design the software reliability and safety is critical in preventing recalls.
Attend this training to learn proven techniques for designing reliable and safe medical device software that can prevent product recalls.
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.
Exhaustive system testing.