DEVICE MANUFACTURER CONTRACTS WITH SUPPLIERS SHOULD SPECIFY TYPES OF COMPONENT CHANGES TO BE REPORTED UNDER QS REG, FDA'S TRAUTMAN SAYS
This article was originally published in The Gray Sheet
Medical device manufacturer contracts with suppliers, consultants or contractors should whenever possible specify the types of changes to the component or service that the supplier must report to the manufacturer, Kim Trautman, quality systems expert in FDA's Center for Devices and Radiological Health, said in a training video aired Oct. 31 at a Regulatory Affairs Professional Society meeting in Bethesda, Maryland.
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