Hi everyone:
I am reading the MDCG-2020-3, as the chart below (software), I have few question,
1. If the we change the appearance of user interface (UI) without affect the performance and safety. What's the direction of flow In Chart C (C5)? Yes or NO?
The reason I want to ask this question is, in C6, the minor change without impact to diagnosis or treatment delivered may include:
A. Appearance of the user interface,
B. Changes to enhance the user interface without changes in performance.
If any change of UI is belonged to "Yes"(like A)in C5, there is no one can go to C6. I think C6 and C5 are contradictory.
2. For the Presentation of data, it is connected to medical data which are presented in a "new format" or by a new dimension or measuring unit. Does it mean the presentation of data in diagnosis report or in UI? What's the mean of "new format"? If we add the item in diagnosis report, does it belong to "new format"?
Thanks a lot.
I am reading the MDCG-2020-3, as the chart below (software), I have few question,
1. If the we change the appearance of user interface (UI) without affect the performance and safety. What's the direction of flow In Chart C (C5)? Yes or NO?
The reason I want to ask this question is, in C6, the minor change without impact to diagnosis or treatment delivered may include:
A. Appearance of the user interface,
B. Changes to enhance the user interface without changes in performance.
If any change of UI is belonged to "Yes"(like A)in C5, there is no one can go to C6. I think C6 and C5 are contradictory.
2. For the Presentation of data, it is connected to medical data which are presented in a "new format" or by a new dimension or measuring unit. Does it mean the presentation of data in diagnosis report or in UI? What's the mean of "new format"? If we add the item in diagnosis report, does it belong to "new format"?

Thanks a lot.