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Does ISO 13485 or MDR require you to state the origins of customer requirements or user needs?

#1
A question came up from our CTO as to whether ISO 13485 or the new MDR require you to state in your documentation how we developed our customer requirements, which we call user needs? Would we need to be able to reconstruct for an auditor the genesis of our user needs or the various sources of the information?
 
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Ronen E

Problem Solver
Staff member
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#2
It is a recommended best practice but I'm not currently aware of such a requirement spelled out.

The establishment of initial User/Customer Needs is somewhere in the borderline grey area between "research"/"feasibility" and orderly Design Control (the former sometimes conveniently, and not against the standard, excluded from Design Control conventions and practices). In many cases most of the User Needs are already discovered in the earlier (read: uncontrolled) stages, then carried over into the Design Input, maybe with an additional orderly process to ensure nothing important has been left out. However, sometimes (I think it's quite rare) the project begins with only a vague concept of the need / Intended Use, and the User Needs are actually worded from scratch under Design Control (Design Input stage). So it can go both ways.
 

somashekar

Staff member
Super Moderator
#3
A question came up from our CTO as to whether ISO 13485 or the new MDR require you to state in your documentation how we developed our customer requirements, which we call user needs? Would we need to be able to reconstruct for an auditor the genesis of our user needs or the various sources of the information?
First up., please don't do anything for an auditor.
Now, the user needs inflow come from various sources, and at some point of time people begin to wonder where a specific need came from.
So it makes sense to have a mention of the source of the input that you have considered.
User needs as you incorporate will add to the cost of the device, and at certain levels of design review when the design inputs vs costs are debated, knowing the input source well, will help in making informed decision about its consideration.
So I believe its a good practice.
 
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