| Abstract: | Embedding defective software in medical devices increases safety risks. Given that all software is inherently defective, how can medical device manufacturers identify and manage risk? An effective, tailored risk management process can make the task less daunting. Developing complex, software-based medical devices is a challenging business. Device manufacturers must understand the inherent differences between hardware and software components and establish robust software development processes that are based on recognized engineering principles appropriate for safety-critical systems. At the heart of such processes, they must incorporate risk management - from early development through product retirement. Manufacturers have a responsibility to train development and risk management teams in the use of recognized software engineering practice that promote software safety. Only then can they minimize the risk of including inherently defective software in their products. |
