I have found all the earlier posts informative and very interesting but some other problems associated with failure to establish a robust design control system is that it can:
Lead to the development of product which is not “suitable for use”
> Inability to be able to correct issues once a product is on market
> Open you up to audit observations for violations of CFR’s and ISO standards
> reduction in device fitness for purpose
> failure to protect those involved in clinical evaluations
> in-market device modifications
> loss of company image
> liability and litigation
> user injuries and deaths