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Supplied item design verification

#1
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?
 

Ronen E

Problem Solver
Staff member
Super Moderator
#2
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?
Short answer: most likely yes.
You might be interested in my article about design verification of medical devices.
 
#3
Thanks for your reply and link to your article on DV, Ronen.

As a follow up, i have another question. In terms of supplied component qualification, my counterpart says that it only involves FAI ( first article inspections). But there needs to be a separate process validation. I believe FAIs can be done for x (typically 3)lots of produced parts; thereby incorporating process variances. I don't see a separate need for conducting three things. So in essence, same samples can be tested for output parameters and leveraged as design verification, component qualification and component manufacturing process validation. Since the component has few variance in design and, the process is a well established industry standard process. This may sound vague but does it sound doable to leverage same data for all three?
 

Ronen E

Problem Solver
Staff member
Super Moderator
#4
It might be possible if you have access to the raw data - depending on what data is available. I really can't give a more specific answer without getting involved.
 

yodon

Staff member
Super Moderator
#5
On the question of whether the test results can be leveraged for design verification (and without reading @Ronen E's article), remember that you are ultimately responsible for the (overall) verification. Does the data you get from the supplier have sufficient integrity? Does it meet the requirements for design verification?
 
#6
Thank you Yodon. Yes, I do beleive the supplier is providing with sufficient integrity with proper inspections and samping rates in place. We will also doing these tests as part of FAIs that will provide additional evidence towards verification testing.
 
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