Design controls specify requirements for design changes under section 820.30 (i) Design Changes:
“Each manufacturer shall establish and maintain procedures for the identification, documentation, validation or—where appropriate—verification, review, and approval of design changes before their implementation.”
This section provides guidance for controlling changes and modifications in the design of the device during the product development phase with an aim to ensure that design requirements are met before transferring to the production phase. These changes and updates come under design change procedure.
The design changes may happen early in the design process (pre-production changes) or after design being transferred to production (and post-production design changes). But early changes are relatively less expensive. The pre-production changes can happen in the conceptualization or ideation stage, prototype stage or testing stage.
