When assessing (significant) changes, it’s all about what you’re changing, not what your new version number will look like. See the answer linked above.
Consider this thought experiment: Instead of semver, you use a versioning scheme which just has one integer number which is incremented. So the first release would be version 1 and the 25th release would be version 25. There’s no way to tell which release contains “major” changes in the semver sense. But some of those changes might still have been significant in the context of a medical device.
So: Use whatever versioning scheme you want, increment the numbers however you like, but assess the content of your changes whether they’re significant.
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