1. Coping with Defective Software in Medical Devices.
- Author
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Rakitin, Steven R.
- Subjects
- *
MEDICAL equipment , *BIOMEDICAL engineering , *MEDICAL supplies , *SCIENTIFIC apparatus & instruments , *RISK management in business , *MANUFACTURING defects , *QUALITY control , *COMPUTER software , *SOFTWARE architecture - Abstract
The article focuses on the problems of coping up with defective computer software in medical instruments and apparatus. Significantly, it is a challenge for manufacturers to identify and mitigate the risks associated with embedding defective software in the devices. The identification and quantification of the potential effects of defective software components is difficult which is different from the other types of components. However, it has failed to ensure that software-based medical devices are safe and effective. Finally, meeting such responsibility needs management commitment, familiarity with software safety, and the adoption of a risk management system.
- Published
- 2006
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