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hello and welcome to my next executive series video our topic is design validation aaron snyder here from quality systems explained where we make quality systems simple for you if you're new to my channel please hit the subscribe button if this is the first executive series video you've seen please go back and watch the introduction video in the video description below you can find links to any supporting information in a summary of the information that we will cover in my executive series we have a standard agenda which consists of four items you can see those four items in the actual progress bar below make sure you stick around to the end of the video to get those three bonus questions our requirement design validation comes directly from 820.30g and iso 1345 section 7.3.7 design validation in five words user testing confirms intended use you have to have procedures that manage how you do design validation design validation itself has to be done under defined operating conditions on initial production units or their equivalents the design validation itself has to show that the user needs and the intended uses are met either through simulated use or actual use conditions actual use conditions are clinical trials clinical trials have to be done according to any local regulatory requirements in design validation we have to do software validation if our product has software and we have to utilize risk management as appropriate throughout the design and development of our medical device you must have all your design validation activities complete before your product is released to market you have to consider human factors and you have to validate your labeling and your ifus as well your design validation records have to include the design itself the date the people doing the validation work the methods used the statistical techniques your acceptance criteria and any deviations from your pre-approved protocol so how do i know my design validation is working well first you have a pre-approved protocol that defines all the activities to be done during validation and also your acceptance criteria second if you're doing clinical trials actual human testing then you're complying with all applicable regulatory requirements third your design validation actually shows that your intended use is actually met for the all users and all environments finally all of the results of your design validation are summarized in a report that's approved before your product is released so how do i know it's not working first you don't have a pre-approved protocol with pre-approved acceptance criteria second you're not taking into account human factors and you're not validating your labeling third validation failures deviations are ignored and not addressed and finally the validation report itself is not approved before the product is released to market now for those three bonus questions do we do any testing on human subjects clinical trials and how is that managed second how do we handle ifu and labeling validations third how...