Example Medical Device Validation Plan and Report wanted


Super Moderator
A Validation Plan is going to be unique to the system being validated. For example, a plan for tweezers is going to be vastly different from one for a robotic surgery system.

You first need to consider what your user needs and intended use are (the 'V' model). How do you provide objective evidence that your system meets user needs and intended use?

Can you provide more detail on what your product is? Maybe ask some specific questions about the Plan?


Starting to get Involved
Thanks for sharing. We are preparing verification and validation for medical equipment.
For verification we are referring DRS (Design requirements) SRS (Software requirements) usability (usability specification)

For Validation what are the requirements need to focus.

For Example is field evaluation is Validation - Kindly confirm.

or IO, OQ,PQ is consider as validation?

Or only user needs is IEC standard excluded or included ?

It will be helpful for us to design validation plan and reports.




Super Moderator
Again, without knowing your specific application, it's not possible to provide much guidance. Design validation is demonstrating that your user needs and intended uses are met. Normally, these high-level requirements are elaborated in a user needs or customer requirements specification. Those are then translated into system requirements (which are verified).

Field evaluation / clinical trials are certainly one aspect of validation. Usability is also a validation consideration (see IEC 62366 or HE 75). I also consider product safety testing (IEC 60601) part of validation.

IQ, OQ, and PQ are more associated with process validation and not generally considered product validation.

To understand the complete scope of your validation needs, though, you need to know the full scope of your user needs and intended uses.

Since you posted in the CE marking forum, maybe look at the essential requirements. Those are, after all, user needs. That may not establish the full scope but will certainly need to be addressed.
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