Robert,
We provide 510(k) templates (eCopy-compliant and verified through FDA submission) as part of our LIVE online training for 510(k)s, specific for eCopy requirements.
In our 510(k) templates in word, you can just fill in the blanks and then save them in PDFs as it was originally saved unless you want to customize the contents (e.g., section by section or volume by volume).
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Original Message:
Sent: 04-09-2013 12:27
From: Robert Wilkinson
Subject: 510(k) eCopy
Does there happen to be a commercially available software medium which contains an FDA acceptable template version of the 510(k) eCopy requirements.
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Robert Wilkinson
President
Resolute Regulatory Affairs Consulting Service, Inc
Port Barrington IL
United States
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