Design Output

Design Output

The next procedure required for the Design process is related to Design Output. Design Outputs are the results of the design efforts, typically coming together as a product specification. During the Design Input process, or immediately following, these Design Output documents need to be prepared: Component and raw material specifications, product/process specifications, drawings, software code,…

Design Input

Design Input

As discussed in the last post, there is specific documentation that needs to be in place for the design process. This week we will cover the topic of design input, and in following weeks we will address the other required design procedures. Design and development activities can be performed to create new products or to…

Control Over the Design Process

Design Control

The next series of “facts” is about Design requirements. The FDA requires all Class II or III medical device manufacturers to prove that they have control over their design process. Design controls provide evidence that there has been a method employed during the product development stage. The intent is to have a system in place…