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Proving Substantial Equivalence in Software Medical Devices


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Hi All.

I have read a few posts about sample plans around design validation and all the examples seem to typically be in relation to manufacturing. Does anyone have any experience with proving substantial equivalence for a Software Medical Device.

There does not seem to be any specific guidance around this that I have found so far.



Staff member
Super Moderator
Let's break this down a little:
* Design verification is demonstration (with objective evidence) that your device correctly implements the requirements you define
* Design validation is demonstration (with objective evidence) that you meet your user needs and intended use

Demonstrating substantial equivalence is providing evidence that your device performs as well or better than another, cleared device with the same claims. You will certainly leverage your design V&V results but they may not be sufficient to fully demonstrate substantial equivalence. To assert substantial equivalence, you need to know what the claims and performance characteristics are for the predicate device. A regulatory expert would be best suited to help you on that path.


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I am performing a search for predicates to see what claims are being made for those predicates. How do I go about it?
I have product code and product description for our device.

On adding that information to the link below, I get a lot of product codes, but how do I know what claims are made? Thanks!
510(k) Premarket Notification
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