Category Archives: Device Modifications

Design Changes: Before, During and After a 510(k) Submission

This article provides advice on how to manage design changes throughout the regulatory submission process for a 510(k) submission. Your design control procedure defines the process for controlling design changes, but how to do you control design changes in relation to your 510(k) submission process? Design Changes Before You Submit a 510(k) Submission Design teams are always implementing design changes

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