DesignAssurance
Starting to get Involved
Our product is a class 3 medical device in development stage. We have some design inputs that are solely related to a component that is being supplied by a supplier. These design inputs relate to variable tests that are dimension measurements related like surface area, length. These specifications do not change and are not affected after assembling to the rest of the components. The component is a custom part and is supplied and assembled as is. Can the supplied component qualification that includes testing the components to output parameters ( same as those defined in the design inputs) be leveraged as design verification for those design inputs?