Abstract
With an increasing number of medical device features being implemented in code, the amount of software that is present in a modern device as well as its complexity and criticality has grown sharply over the years. Existing quality-control regimes for software, dependent as they are on traditional inspection and ad-hoc testing techniques, has been unable to meet many of these challenges. The numbers tell the story. In 1998, close to 8% of device failures could be traced to software errors. Currently, the number of device recalls due to software problems is believed by some to be about 18%. Model-based development (MBD) is often suggested as a candidate solution, a novel way of doing software development and quality control. So what is model-based development and what it does it mean for professioals working in the medical instrumentation field? Read on.
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