I agree with what everyone has already said about inefficient design control leading to dangerous devices, lower quality, traceability of the product, or the FDA not allowing the product to get to the market. To add to all of this, design control is also a key factor in fixing any problems that arise. The Design History File (DHF) contains all of the design control documents, logs the design process, and is frozen once the product is created. The Device Master Record (DMR) is a continuously updated folder that contains everything about the product from scratch to finish.If a device fails a company should be able to go back and look at the DHF and DMR to see exactly where the design process or design change went wrong. If a company does not keep good records because of a poor design control process it can be very difficult to see where the product failed and how to fix it.