Jong Ho "Philip" Won, Ph.D.

Jong Ho "Philip" Won, Ph.D.

Alston & Bird

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Addressing Data Integrity Challenges in Medical Device Submissions

The Food and Drug Administration’s (FDA) recent rejection of all study data from Mid-Link Testing highlights the importance of using reliable, valid data for medical device premarket submissions. Our FDA/Food, Drug & Device...more

4/16/2025  /  Audits , Compliance , Data Integrity , Food and Drug Administration (FDA) , Healthcare , Manufacturers , Medical Devices , Regulatory Requirements , Risk Management , Third-Party
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