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tnkirk t1_ix2hdl5 wrote

What did your verification and validation protocols look like for this kind of software?

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EzekielNOR OP t1_ix2wiii wrote

Everything we did was ran through medical professionals and the users for feedback and adjustments. We had user workshops to get detailed feedback and see real life use cases outside the clinical usage at the VR Lab.

Continued clinical usage is planned.

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nklsoe t1_ix3e6vq wrote

isnt a software like this a class III medical device? are you planning on doing the full conformity assessment process if it qualifies as such?

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EzekielNOR OP t1_ix3emre wrote

It isn’t much different from software like Beat Saber and similar when it comes to requirements. However, we’ve gone through conformity assessments in a ROS analysis to make sure patient data is sufficiently protected.

If the software was to be developed further it would be sensible to start extended clinical trials.

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