Validating Custom adaptations of Medical Devices

Q

Quality Priest

#11
Re: Custom adaptation

Hello to all - First post :bigwave:
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.
I also work for a medical device manufacture and am in agreement with Gert, your validation work could comprise of your welding and cutting process, then you are only looking at the fit form and function of the finished product.

I have validated several products where the materials were bough in, and in these cases glued together. The validation work was on the suitability of the glue process.

Should not be a great deal of difference between FDA and MHRA acceptability of validation, the only other thing to consider is justification of functionality of the product, which is something you may have to work with your customer on.
 
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#12
We make custom built wheelchairs. There are several standard bases with the motors and several seats that will be configured for the client. If you are wide the seat will be wide. If you are tall the legrests will be long. These are all covered in the original spec. Where I run into an issue is dealing with the special adaptations. Someone who is an amputee might have to have a support structure that is not covered in my regular options. We will build the support for the person.

A prescription is done for the tilt and recline features or for sideways tilt. This has to do with circulation or pressure relief. This has to do more with what insurance will pay for in each clients case.

We are getting an order from a dealer not a Doctor so I don't think a prescription applies.

I did some reasearch using the denture idea from an earlier post and have learned quite a bit.

There is a section of code that allows for custom devices. There is not a hard a fast rule about how many you can make before it becomes a standard part. I get a figure of about 10 pieces. We are generally not going to custom make more than 10 of the same part in a year. Custom really is custom.

I am pretty confortable with the guidance that I have found at the FDA (section 520(b) 0f 21 USC 360j(b) along with the great help from here on the Cove.

Thanks to everyone.
 
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