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It’s Time to Get IEC 62304 Before It Gets You

Compliance is determined by a review of all required documentation, including risk management

Russ King
Wed, 09/24/2014 - 10:50
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Food and Drug Administration (FDA) medical device recalls are on the rise. An increasingly active FDA coupled with an increase of medical device software components is adding up to new challenges for manufacturers. It’s important to understand how the FDA uses IEC 62304, an international standard developed by the International Electrotechnical Commission (IEC) that, among other things, says product testing by itself is not enough to prove software is safe for patients using the medical device.

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