Navigating Medical Device Design Control & Risk Management
Helping you navigate integrated design control and risk management, while providing complete visibility into the entire development process for your medical device.
In your product development cycle, your teams get heavily involved in usability engineering—particularly during risk management. This process is meant to be intensive: the more exhaustive your team’s efforts in identifying as many user interactions as possible, the greater benefits they yield. FDA is then satisfied you have applied their “Inherent Safety by Design” principle, and there is less overall risk to the user.
With the growing risks of potentially fatal hacks of interconnected medical devices, FDA is more concerned than ever that product development teams are incorporating robust cybersecurity measures into their device design. No matter what measures teams decide to implement, FDA’s main concern is for maximizing user safety while mitigating risk as much as possible.
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