Validating Custom adaptations of Medical Devices

#1
I work for a medical device manufacture that brings in 80% finished product that is custom fit to clients. We do the final assembly and this "Custom" work. Some of this work is routine (make a piece 2" shorter) some does involve custom bending of sheet stock and welding. I can't possibly cover every adaptaion in the MDR. I do cover every adaptation in the DHR. I'm not sure this is enough to satisfy validation for this change. Any comments on this will be very helpful.

As far as what needs to be changed think of someone with partial use of their right hand. Some people can use 2 fingers some 3 and so on, we have to accomodate all of these but can not anticipate or test every iteration.

Thanks
 
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Gert Sorensen

#2
Re: Custom adaptation

I moved your post to this forum, where we might get some more useful input.

I can't possibly cover every adaptaion in the MDR. I do cover every adaptation in the DHR.
Do you need to cover it? Is it possible for the MDR to document the product to stage X, and then let the DHR cover it from stage X to Y? If it were described in your system how you organize it, then this might be a possibility. I would consult my Notifying Body on things like this to get their input.

I'm not sure this is enough to satisfy validation for this change. Any comments on this will be very helpful.
Why would you validate this? What is the rationale behind that decision?
 

Al Rosen

Staff member
Super Moderator
#3
Re: Custom adaptation

I work for a medical device manufacture that brings in 80% finished product that is custom fit to clients. We do the final assembly and this "Custom" work. Some of this work is routine (make a piece 2" shorter) some does involve custom bending of sheet stock and welding. I can't possibly cover every adaptaion in the MDR. I do cover every adaptation in the DHR. I'm not sure this is enough to satisfy validation for this change. Any comments on this will be very helpful.

As far as what needs to be changed think of someone with partial use of their right hand. Some people can use 2 fingers some 3 and so on, we have to accomodate all of these but can not anticipate or test every iteration.

Thanks
Could this be similar to contact lenses or dentures? I wonder what someone would do in that situation?
 

Al Rosen

Staff member
Super Moderator
#4
Re: Custom adaptation

Do you need to cover it? Is it possible for the MDR to document the product to stage X, and then let the DHR cover it from stage X to Y? If it were described in your system how you organize it, then this might be a possibility. I would consult my Notifying Body on things like this to get their input.
There is no Notified Body in the US, only FDA.
:jawdrop:
 
#5
Re: Custom adaptation

Thanks for moving the thread.

I had not thought about dentures, it is kind of the same idea.

As far as validation goes I mean our product is tested in certain configurations (think seat belts in a car). If I change the mounting location for these I can't show a new test report for the change. Be mindful that I made the change because the client can't use the device unless I make the change.

I can show a trail through the device history file. What I'm not sure about is if that is enough of a trail back to the MDR.

Thanks
 
G

Gert Sorensen

#7
Re: Custom adaptation

Thanks for moving the thread.

I had not thought about dentures, it is kind of the same idea.

As far as validation goes I mean our product is tested in certain configurations (think seat belts in a car). If I change the mounting location for these I can't show a new test report for the change. Be mindful that I made the change because the client can't use the device unless I make the change.

I can show a trail through the device history file. What I'm not sure about is if that is enough of a trail back to the MDR.

Thanks
I do not see the need for validation in this case. IMO you need to test the individual custom made pieces thorougly to make sure that the piece will perform as expected by the customer (given the fact that it is custom made I am guessing protesis?). The normal interpretation is that you need to validate a process if you can not feasably verify the outcoming result. Usually it would need to be a repetitive process. In this case I think that you should consider recording and proving your employees ability to perform the task at hand: Welding, bending etc. to ensure that the outcoming result will be satisfactory. Aditionally you could/should have some defined criteria for the performance of the produced item, and you should verify that these have been met.

Have you considered contacting FDA for guidance on the requirements for the documentation in these kinds of matters?
 

Al Rosen

Staff member
Super Moderator
#8
Re: Custom adaptation

:topic: Who approves and gives certifications under ISO or QS then??
The OP was in the FDA forum before you moved it to the ISO 13485 forum. The OP made references to terms MDR (I assumed from the context that he meant DMR) & DHR (here I thought he meant DHF for Design History File not Design History Record). These are common to FDA. Notified Bodies are more concerned with the Technical File rather than DMRs, DHFs and DHRs.
 
#9
Thanks for the input. I was out sick for 2 days so I have not looked at the forum. I meant to put DMR in the 1st post. Which is the Device Master Record. This is the procedures and specs for the device. The DHR is the Device History Record which is all of the records that show the device was made in accordance with the DMR.

I've been doing some research on the dentures and I think this may lead me down the correct path. I don't have it in front of me so I can not cite the reference but I will post it some time today.

Thanks to all.
 
S

sanjoh

#10
I work for a medical device manufacture that brings in 80% finished product that is custom fit to clients. We do the final assembly and this "Custom" work. Some of this work is routine (make a piece 2" shorter) some does involve custom bending of sheet stock and welding. I can't possibly cover every adaptaion in the MDR. I do cover every adaptation in the DHR. I'm not sure this is enough to satisfy validation for this change. Any comments on this will be very helpful.

As far as what needs to be changed think of someone with partial use of their right hand. Some people can use 2 fingers some 3 and so on, we have to accomodate all of these but can not anticipate or test every iteration.

Thanks
Is the "Custom" built to a prescription from a Physician?
 
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