Oct 3, 2022 · An electronic copy (eCopy) is an electronic version of your medical device submission. An electronic copy is not considered an electronic submission.

The page contains a list of Frequently Asked Questions about the eCopy program for medical device submissions.

Jan 14, 2026 · eCopy PaperWorks, now part of the Kofax imaging suite, is a robust document management solution designed to bridge the gap between paper-based workflows and digital efficiency.

Nov 16, 2025 · eCopy Desktop works with most network fax, e-mail and document management applications, including Lotus Notes, Microsoft Outlook/Exchange, Interwoven WorkSite, Lotus …

The inclusion of an eCopy is expected to improve the efficiency of the review process by allowing for the immediate availability of an electronic version for review rather than relying solely on...

Dec 5, 2025 · Use CDRH’s Customer Collaboration Portal secure website to send eSTAR and eCopy premarket submissions and track progress of 510 (k) submissions online.

Aug 5, 2009 · eCopy PaperWorks enables office workers to convert electronic and paper documents into text-searchable, secure PDFs and directly include them in business applications and workflows.

Dec 7, 2025 · An eCopy is a complete electronic version of a medical device submission provided on CD, DVD, flash drive, or electronically through the CDRH Portal or CBER’s ESG NextGen system.

The eCopy hold notification will describe the reasons for the eCopy failure and the logistics for submitting a replacement eCopy. It is important that you follow these directions to avoid delays in …

At Ecopy Services, we simplify information management for healthcare providers and legal professionals. Our comprehensive suite of services streamlines your workflow, enhances security, …