FDA’s Validated IFU Requirements For “High Risk” Devices (Part II)

Archive for: December, 2019

News

FDA’s Validated IFU Requirements For “High Risk” Devices (Part II)

In Part I of this blog (Novo blog number 115, 12/13/19) we pointed out that “The #1 responsibility of everyone involved in reusable medical device processing is to minimize the risk of patient harm caused by a device that remains contaminated with organic debris after processing.” The responsibility to minimize...

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News

FDA’s Validated IFU Requirements For “High Risk” Devices (Part I)

The #1 responsibility of everyone involved in reusable medical device processing is to minimize the risk of patient harm caused by a device that remains contaminated with organic debris after processing. This responsibility begins with pre-cleaning the device at point of use and it continues through all of the processing...

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