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Hi all,
A little while ago i posted regarding CE certification for a new medical product .
I'm now a little further along in the process and a lot more understanding of whats needed for CE certification
I'm now at the ISO 13485 stage and was wondering if anyone could recommend a good resource for a novice
The product itself is a class 2a medical device used for the automated diagnosis of spinal problems from CT scans.
I want to work out what processes i specifically need to document and what processes i actually need to complete and then document!
I did find a good post here with a checklist but am after a bit more detail.
How much Process Description is required or needed?
Thank you very much for taking the time to read this! and any help is very welcome
/beastie
A little while ago i posted regarding CE certification for a new medical product .
I'm now a little further along in the process and a lot more understanding of whats needed for CE certification
I'm now at the ISO 13485 stage and was wondering if anyone could recommend a good resource for a novice
The product itself is a class 2a medical device used for the automated diagnosis of spinal problems from CT scans.
I want to work out what processes i specifically need to document and what processes i actually need to complete and then document!
I did find a good post here with a checklist but am after a bit more detail.
How much Process Description is required or needed?
Thank you very much for taking the time to read this! and any help is very welcome
/beastie
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