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What’s the Difference Between Premarket Notification 510(k) and Premarket Approval (PMA)?

[fa icon="calendar'] Mar 28, 2018 4:48:40 PM / by Leslie Standridge posted in Medical Devices, FDA, pma, 510(k), premarket approval, premarket notification

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Qualio's Quick Guide to FDA Medical Device Classification

[fa icon="calendar'] Mar 13, 2018 2:05:01 PM / by Leslie Standridge posted in Medical Devices, FDA

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FDA Provides Wellness Device Testing Guidelines. What's Your Next Move?

[fa icon="calendar'] Sep 7, 2016 3:25:07 PM / by Pat Flanders posted in Quality & Compliance, Medical Devices, FDA

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Last month, the US Food and Drug Administration (FDA) released a document that provides guidelines and compliance information for companies that manufacture wellness devices. As opposed to devices that are invasive or provide extensive screening or testing capabilities, wellness devices are in a category the FDA considers "low risk", and outlines the classification within the document.

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