After last week’s focuses on the phases of a project and design controls. This combined with FDA regulations lays out a very strict process for which a medical device is to be created. This week’s forum involved one post about safety recalls and another post about inadequate device testing. As already discussed in these posts, medical device production is not always perfect and sometimes their side effects can be severe. My question is what needs to improve in either the design process or FDA regulation to ensure that no short cuts are taken and medical devices will not harm their users.