First 510(k) submission - Class II software as medical device

#1
Hello,

We are a start-up company and I'm working in our first 510(k) submission (Class II software as medical device) and I'm sorry for my stupid question but I'm preparing the submission putting all the documents together and I don't know how to put report information into the 510(k). I created a 510(k) structure and I'm coping there all the device information, but as the verification and validation are signed documents I'm not sure if I have to annex the info later (but I will have problems with the page numbering) or if I can just make a copy and paste without the signatures. Could you help me?
 
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#2
Hello,

We are a start-up company and I'm working in our first 510(k) submission (Class II software as medical device) and I'm sorry for my stupid question but I'm preparing the submission putting all the documents together and I don't know how to put report information into the 510(k). I created a 510(k) structure and I'm coping there all the device information, but as the verification and validation are signed documents I'm not sure if I have to annex the info later (but I will have problems with the page numbering) or if I can just make a copy and paste without the signatures. Could you help me?
Hi Tiffany, I guess you are also preparing the summaries (such as Performance Testing-Bench). So, while preparing the summaries you can refer your test report as "Attachment" and include it along with the summary. I have quickly drafted a sample document for you to give you an idea. By doing this you don't need to worry about the pagination for the report. And, I will suggest to provide the signed reports.
 

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