Is the software or app is regulated

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Reference no: EM133664565

Assignment:

We need to discuss and provide reflection about Any Baby Movement Apps ( one hundred fifty words)

We have to review the choosen app and reach to the conclusion whether it is SaaS, SaMD or medical software and provide justification in the reflection

Questions need to cover -

is the software or app is regulated?
Is it's purpose likely to be medical?
is it excluded? Does the software meet the exclusion criteria?
is the clinical decision support software exempt?

Reference

• Therapeutics Goods Administration. February 2021. Examples of regulated and unregulated software (excluded) software based medical devices, Draft 1.1.

• Therapeutics Goods Administration. February 2021. Is my software regulated?

Reference no: EM133664565

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