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Read more about the article How to determine if your software is an FDA regulated medical device.
Regulatory

How to determine if your software is an FDA regulated medical device.

Developing a health app for mobile phones? Then you're probably wondering if your app is a regulated medical device. Same question if you're developing any computer software being used in…

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20 November 2021
Read more about the article The ultimate list of FDA regulations and guidelines for software medical device engineering and 510(k) clearance.
Regulatory

The ultimate list of FDA regulations and guidelines for software medical device engineering and 510(k) clearance.

The FDA publishes clear regulations and guidance to manufacturers for developing and marketing their regulated medical device. But if you don't know what is out there or where to look,…

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25 October 2021

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