Software in Medical Devices, a blog by MD101 Consulting

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Want to post a medical App on Apple Store? Things get harder!

Apple now asking app developers to provide sources of medical information says imedicalapps.com web site.

Looks like Apple wants to put the pressure on medical app developers. According to this article, the review is extended to a kind of validation of the apps. Apple wants now to validate source of the medical information contained in the app

This new validation process somewhat overlaps the validation requested by the FDA (21 CFR 820.3) or by the CE mark process (Essential Requirement #6bis) or any other national regulation.
Despite Apple's legitimate will to discard ineffective apps, it raises more questions that it solves!



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