Appropriate procedures for design controls is a critical requirement of 21 CFR 820.30 to ensure the product development follows a systematic approach while documenting the decisions made along the way. Insufficient/ Inappropriate design control procedures will result in inconsistency developing products which could translate to product failures and consequently patient risk/ harm. Also, if the procedures to development a product are insufficient and did not follow a documented systematic approach, it will be difficult to maintain quality of the product, for example, during complaint handling performing complaint investigation and looping back into the design if the design (DHF) was not properly documented in the first place.