Design vs. Process Validation

  • 2 March 2022
  • 2 replies

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What is the difference in Design Validation and Process Validation?

Are there any best-practices that we can use to make sure we are staying compliant? Or any guidance documents that help explain this?


Best answer by JMarkley 8 July 2022, 21:48

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Hello Etienne,

Design Validation is the establishment through objective evidence that the device specifications conform to intended use and user needs. 

Process Validation is the establishment through objective evidence that a process consistently produces product that conforms to its established specifications. 


Design Validation provides confidence at a level based on sampling plans selected that the product, as currently designed, meets the needs of end use and Process Validation provides confidence that the processes used to produce said conforming product do so at a level based on sampling plans selected. All of this should be done at levels appropriately balanced between device risk, risk control measures, and complexity/cost of testing. 

A great book that explains this and provides guidance on selection of appropriate techniques and sampling plans is Statistical Procedures for the Medical Device Industry by Dr. Wayne Taylor. 

Taylor, Wayne (2017). Statistical Procedures for the Medical Device Industry. Taylor Enterprises, Inc., 


Best Regards,


Userlevel 5
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@JMarkley very concise answer - thank you sir! 

Also, I saw your introductory post about your favorite titles being husband and dad - your whole post resonated with me, I have a 4-yr old and 2-yr old boy as well that are major sources of entropy, but oh-so-worth it! 

Glad to see you around the community,

All the best,
Etienne Nichols