Per 21 CFR Part 820, "Each manufacturer of any class III or class II device shall establish?and maintain the procedures to control the design of the device in order to ensure that specified design requirements are met." Compliance with this regulation is documented in the Design History File (DHF) and results in the creation and management of many documents specific to the development history of the medical device.
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MasterControl automates medical device GxP processes to improve efficiency and speed time to market. Processes include: