Expert Insights | Engineering

Explore practical guidance to help medical technology teams reduce risk, make informed decisions, and bring life-changing products to patients faster.
Five Major Principles for Predetermined Change Control Plans Regarding Machine Learning-Enabled Devices
abstract graphic representing machine learning

Five Major Principles for Predetermined Change Control Plans Regarding Machine Learning-Enabled Devices

October 30, 2023 4 min read
Understanding FDA’s New Guidance Document on Human Factors Information in Medical Device Submissions
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Understanding FDA’s New Guidance Document on Human Factors Information in Medical Device Submissions

January 18, 2023 5 min read

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