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Hi everyone,
Please keep in mind that i am no engineer of any sort but I have to get this sorted out myself to even ask the engineer what to do.. which I have no luck right now
So first of all we are trying to get fda approved for a x-ray PACS and viewer type of software for a medical x-ray system. Currently our program uses 'leadtool medical imaging suite' and 'magic cd/dvd server'.
Yes, I have read guidance regaring off the shelf software on fda website and.. i just get more and more confused (and depressed)
1. Do I need OTS sofrware documentation? (pls say no!!!) Our engineer keeps on saying how its a library and it is not a program.. then again I really cant understand what he is saying really ...
Please ignore me if i am wrong but I guess codes from 'leadtool medical imaging suite' are used to make our software (for example part of image archiving, searching fuction etc.)
2. If I do need OTS software documentation.........Please help. I tried to explain the fda guidance to the engineer but he just dont understand (or pretends to.. hmm). Partly is probably because I have no idea on softwares... especially codes.... or whatever it is so I cant even explain properly. Please help me what I have to ask my engineer to create for me. Yes I am aware that this entire document has to be created by the engineer maybe even from the beginning but.. well..
Please help and I really appreciate any sort of comments, advices and solutions!!
Thank youuuu
Please keep in mind that i am no engineer of any sort but I have to get this sorted out myself to even ask the engineer what to do.. which I have no luck right now
So first of all we are trying to get fda approved for a x-ray PACS and viewer type of software for a medical x-ray system. Currently our program uses 'leadtool medical imaging suite' and 'magic cd/dvd server'.
Yes, I have read guidance regaring off the shelf software on fda website and.. i just get more and more confused (and depressed)
1. Do I need OTS sofrware documentation? (pls say no!!!) Our engineer keeps on saying how its a library and it is not a program.. then again I really cant understand what he is saying really ...
Please ignore me if i am wrong but I guess codes from 'leadtool medical imaging suite' are used to make our software (for example part of image archiving, searching fuction etc.)
2. If I do need OTS software documentation.........Please help. I tried to explain the fda guidance to the engineer but he just dont understand (or pretends to.. hmm). Partly is probably because I have no idea on softwares... especially codes.... or whatever it is so I cant even explain properly. Please help me what I have to ask my engineer to create for me. Yes I am aware that this entire document has to be created by the engineer maybe even from the beginning but.. well..
Please help and I really appreciate any sort of comments, advices and solutions!!
Thank youuuu