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Design Intent: Do I Need to Perform Verification and Validation?

EduQuest, a global team of FDA compliance experts, answers industry’s pressing questions. In this round, Denise Dion, Vice President of Regulatory & Quality Services for EduQuest, offers design insight.

dion119x138Denise Dion, Vice President
of Regulatory and Quality Services for EduQuest

Question: We have characterized a material change to our medical device and have confirmed that there is no impact to any of our design inputs or outputs. Do we still have to formally perform Verification and Validation (V&V)? In other words, is the evidence of no impact from characterization acceptable to justify not performing design V&V?

Answer: Yes—but let’s back up a bit and put this answer into context.

Design verification proves the appropriateness of a design output specification relative to a design input. It answers the question: Is this the correct output specification?

Most design verification is done by analysis, but some is accomplished by inspection, measurement or testing.

In your case, you’ve decided to make a material change; therefore, you are changing a design output specification. As part of your characterization, you’ve determined that the output specification for the new material is consistent with applicable design inputs.

Your analysis has also determined that the new material output specifications have no adverse impact on the other design inputs or outputs associated with the device. If you have documented your characterization studies and your impact analysis, you have performed design verification.

Furthermore, based on that data, it appears that you believe that design validation (performance and functionality and usability, etc. testing) is not required.

   
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Chicago | June 13-15

Verification vs. Validation is one of the most misunderstood aspects of Design Controls. Ms. Dion will clear up misconceptions and provide applicable, actionable examples during her two-hour review of the topic at
OMTEC 2017. 

 
All design changes must be verified and validated, unless you can document that verification alone is appropriate—which it appears that you’ve done, in this case. You should always do design verification for every change, as well as an impact analysis.

Also, you should always demonstrate the correctness or appropriateness of every design output specification.

What’s not always required is performance and functionality testing to prove that—with the new output specification—the new finished device will perform and function as intended and meet your user’s needs.

So, based on what you’ve told me, you have performed design verification and have a scientific justification as to why you don’t believe you need to do design validation. Just make sure that your characterization and analysis are well-documented, even if performed via some sort of design or peer review process.



Ms. Dion has been with EduQuest since 2002, following 18 years with FDA. Her final eight years with FDA were served at headquarters as the medical device investigator liaison between the Office of Regulatory Affairs (ORA) and the Center for Devices and Radiological Health, as well as between ORA headquarters and field staff. EduQuest can be reached by This email address is being protected from spambots. You need JavaScript enabled to view it..

EduQuest

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