There are many risks associated with developing and deploying software for medical devices. One key risk is the potential for software errors that could result in patient harm or even death. To mitigate this risk, software developers must adhere to rigorous standards and best practices for development, testing, and validation.

Software risk management for medical devices is a process by which developers identify, assess, and mitigate risks associated with their software development projects. The goal is to ensure that any errors or vulnerabilities in the software do not put patients at undue risk.

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