Hello fellow colleagues!
Long story short: imagine you want to control remotely your medical device (FDA class II) using an app in your smartphone.
Note this will be the only way of controlling the device (so no buttons on the device itself).
When developing the app, there will be SW features considered as medical (like the control of the device), and others as non-medical (like user statistics recording).
1st question: the best approach is to consider the app as an accessory in the full 510k? or as a system component?
2nd question: can we separate the SW architecture efficiently so that the 510k will only refer the medical functions of the app?
3rd question: if 2nd question is true, what real differences shall we expect from both documentation and SW development perspective? Meaning will it be easier to consider the whole app as a medical app, or split it into like 10%MD + 90%NMD?
Very grateful for your feedback
Long story short: imagine you want to control remotely your medical device (FDA class II) using an app in your smartphone.
Note this will be the only way of controlling the device (so no buttons on the device itself).
When developing the app, there will be SW features considered as medical (like the control of the device), and others as non-medical (like user statistics recording).
1st question: the best approach is to consider the app as an accessory in the full 510k? or as a system component?
2nd question: can we separate the SW architecture efficiently so that the 510k will only refer the medical functions of the app?
3rd question: if 2nd question is true, what real differences shall we expect from both documentation and SW development perspective? Meaning will it be easier to consider the whole app as a medical app, or split it into like 10%MD + 90%NMD?
Very grateful for your feedback
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