Do you test the download and installation of a mobile medical device app?

[SSchoepel]

We have a medical device app we are developing and I'm wondering where I can stop testing.

There are two ways to look at the testing:
1. Use a simulator or use a developer account on the mobile device to run the app and test the features, then submit to Apple and let the review/check that Apple does constitute the download/install testing. (If they approve it, then that covers the app being packaged, downloaded, and installed correctly.)

2. Test the app and features, but use the iTunes Connect beta testing feature which would allow us to download and install from them in a test environment. The beta testing "feature" for iTunes is the same used to submit it to Apple for their testing so I'm wondering if we'd be redundant.

#2 may be more thorough but I'm wondering if it's necessary. Anyone with any experience in where to draw the line?

Thank you.

 

[Stijloor]

A Quick Bump!

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[c.mitch]

Hi,
Tests are usually phased in factory tests and field tests (I'm simplifying).
#1 looks like factory tests and #2 looks like field test. So I would keep both. But for #2 I would go for a reduced test plan (verifying that it works on target platform without dev account) hence deep tests are done in #1.

 

[isoalchemist]

Yeah you are stuck with needing both. I have a slightly different take in that it is really a 3 step process, your internal testing, Test 2 verifying it works with the Apple deployment system, and finally after I know it works get the Apple OK.

I don't believe Apple will dig deep enough into the system to find hidden problems that you are responsible for in the MD world

 

[kreid]

I would have thought that you need to demonstrate that it works on any device that can connect and download from istore. Maybe they have some set of definitions for developers that achieves this?

How are you dealing with IFU and PMS type issues?

 

[SSchoepel]

On the app store you can buy apps that are designed for specific Apple devices. You can say you only support iPhones or iPads, or perhaps iTouch. You can even say you only support iPhones or iPads at a certain release and above.

Apple does have a nice developer site where they explain things, where you can try things, and a staging spot where you can try out your app before submitting it to Apple for their testing/approval.

The IfU will be a PDF and bundled with the app. Not sure how the engineers plan on displaying it. We are not focused on the app yet so this is just leg work for when I need it in a few months.

I don't recognize the acronym PMS for something to consider with the app. Can you define it, please?

 

[c.mitch]

PMS = Post Market Surveillance.
PMS can have many entry points
1. A group of priviledged customer which give periodically their feedback
2. A button or menu entry "report a problem"
3. A feature like "register yourself" to get a list of customers and send them questionaires.

So this is not a problem of PMS. The big problem is recall or withdrawal. How can I know who has the product if I want to recall it. Usually with software, the solution is to activate software only if the user requested a license to rhe vendor. A licencing scheme allows to know who has what.