Hi all,
I've been in Medical Devices quite a while and am a bit embarassed to admit I still don't know what's actually required for a design verification. I have always worked with companies that would verify through extenstve testing that the design output meets a pre-determined design input specification. An example might be that a device "must be able to withstand pressure of up to 20atm". So in order to verify that the desigin output meets this specification, I would have a pre-approved protocol/plan which states the test methodology and equipment to be used, along with the sample size and acceptance criteria (both of which would be determined by the FMEA risk for the associated failuire mode).
However, I come across frequent situations where a product might have a design input specification that, in my opinion, doesn't warrant any testing whatsoever (but the companies I've worked for will still test for it). Some examples might be as follows:
EXAMPLE 1:
USER NEED: Device must be long enough to reach the target treatment area
DESIGN INPUT SPECIFICATION: Top-to-toe length must be at least 30cm
DESIGN OUTPUT: Assembly drawings with allowable top-to-toe length 35-40cm
For this one, would it make sense for Design Verification to simply be a documented verification that 35-40cm is specified on the assembly drawing? Therefore design output meets design input.
EXAMPLE 2:
USER NEED: Device must be visually appealing to the user
DESIGN INPUT SPECIFICATION: Handle on the finished Device must be white (this would just be a partial spec, it would take a lot more to define an appropraite design input for this user need)
DESIGN OUTPUT: Handle component drawings with white specified as the colour
This is probably a controversial example but if we pretend that the spec is based on a user 'need' (rather than a user 'want'), could Design Verification simply be a documented verification that all of the individual drawigns for the handle components specify they be made in white? Therefore the finished device has to end up white.
So my question is in two parts: Firstly, can Design Verification be done like I've suggested in these 2 examples - a paperwork check? Or is testing always needed?
Secondly, if testing is not always needed, then how would you go about satisfying 7.3.6 of ISO 13485 (planning for DV). Would you need to write a protocol/plan up front to state that you're going to take out the approved drawing and compare it to the design input spec?
I understand there are loads of holes in the examples I've picked, but I'm more interested in the concept of Design Verification without testing. Whether that is a common approach that I should be using instead of testing wherever possible? Thanks
I've been in Medical Devices quite a while and am a bit embarassed to admit I still don't know what's actually required for a design verification. I have always worked with companies that would verify through extenstve testing that the design output meets a pre-determined design input specification. An example might be that a device "must be able to withstand pressure of up to 20atm". So in order to verify that the desigin output meets this specification, I would have a pre-approved protocol/plan which states the test methodology and equipment to be used, along with the sample size and acceptance criteria (both of which would be determined by the FMEA risk for the associated failuire mode).
However, I come across frequent situations where a product might have a design input specification that, in my opinion, doesn't warrant any testing whatsoever (but the companies I've worked for will still test for it). Some examples might be as follows:
EXAMPLE 1:
USER NEED: Device must be long enough to reach the target treatment area
DESIGN INPUT SPECIFICATION: Top-to-toe length must be at least 30cm
DESIGN OUTPUT: Assembly drawings with allowable top-to-toe length 35-40cm
For this one, would it make sense for Design Verification to simply be a documented verification that 35-40cm is specified on the assembly drawing? Therefore design output meets design input.
EXAMPLE 2:
USER NEED: Device must be visually appealing to the user
DESIGN INPUT SPECIFICATION: Handle on the finished Device must be white (this would just be a partial spec, it would take a lot more to define an appropraite design input for this user need)
DESIGN OUTPUT: Handle component drawings with white specified as the colour
This is probably a controversial example but if we pretend that the spec is based on a user 'need' (rather than a user 'want'), could Design Verification simply be a documented verification that all of the individual drawigns for the handle components specify they be made in white? Therefore the finished device has to end up white.
So my question is in two parts: Firstly, can Design Verification be done like I've suggested in these 2 examples - a paperwork check? Or is testing always needed?
Secondly, if testing is not always needed, then how would you go about satisfying 7.3.6 of ISO 13485 (planning for DV). Would you need to write a protocol/plan up front to state that you're going to take out the approved drawing and compare it to the design input spec?
I understand there are loads of holes in the examples I've picked, but I'm more interested in the concept of Design Verification without testing. Whether that is a common approach that I should be using instead of testing wherever possible? Thanks