Q
Re: Custom adaptation
Hello to all - First post
Hello to all - First post
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.
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.