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Software in the real world: "How many bugs do you have?"

This article was originally published in Clinica

Executive Summary

Medical device software is often cited as a source of problems in real use by both regulators and manufacturers. Many companies lack a structured approach to software development and often end up fixing "bugs" the expensive way - in the field. But with planning and modest outlay in the design and development stage, many costly problems can be avoided. Tools that make this easier are now emerging, says medical device industry consultant Trevor Lewis, who also suggests that companies learn to use the methods and tools developed in the US and other industries.

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