How should change control be applied to complementary software in medical device projects?

Question

How should change control be implemented for software that complements a medical device? Should the change evaluation apply only to the medical device software, or should it also cover complementary software (e.g., software that interacts with but is not part of the medical device)? If a change to the device requires changes to complementary software, what level of documentation or impact analysis is expected?

Dr. Oliver Eidel · Accepted Answer

Security Use Case Views are scenarios that describe how your system’s security controls would handle specific threats or risks. Basically, they illustrate what happens when the system faces a cybersecurity event, such as an attempted attack, and how it’s supposed to respond.
These views typically include:
• Walkthroughs of the system’s response to attacks or incidents
• Expected behavior under attack (for example, limiting functionality, logging alerts, or notifying users)
• Details on mitigation strategies, fail-safe mechanisms, and incident response plans

Your approach of deriving scenarios from threat modeling and showing the normal vs. compromised data flows sounds like a good way to demonstrate how your controls work in practice. You probably don’t need a scenario for every single threat, but focusing on the highest-risk ones is both useful and illustrative.

How should change control be applied to complementary software in medical device projects?

1 Answer

Keep reading

Software as a Medical Device: What's a Significant Change?

Change Evaluation List

Intended Use (for Medical Devices Under MDD / MDR)