Safety and security are increasingly vital requirements in medical device design, but satisfying these requirements can be challenging, involving significant expertise and effort. Medical device manufacturers have a significant role as integrators of various technologies, often with extensive software bills of materials (SBOMs). Safety and security must be gauged for each component in the system and related applications. Learn more with our guide to designing safe, secure medical devices.
This paper explores how to overcome medical device development challenges, and covers:
- Finding hazards
- Defining safety requirements
- Selecting OTS components
- Complying with standards
- Securing software
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