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Brining the Green Heat 💚#repost @nicolette_shea - Vote for Nicolette Shea best @GreensnProteins shake post of the year 😉 #instagrammeroftheyear #girl #SheaSquad #ecopy #photoshop #mdcommunity #luxury #nominee #foodporn #instagrammer #fanvotingy #nicoletteshea #ecopy #photoshop #greensandproteins (at Greens and Proteins) https://www.instagram.com/p/ByJ7xpIAlxJ/?igshid=11a6jh90901tz
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eCopy
eCopy(electronic copy) is done as a part of the submission package for CDRH (Centre for Devices and Radiological Health). Today, we are going to list some essential parts of an eCopy that one should pay attention to.
These are:
510(k)
De novo
PMA (Premarket approval)
PDP (Product Development Protocol)
IDE (Investigational Device Exemptions)
IND (Investigational New Drug)
BLA (Biologics License Applications)
Pre-submissions
A few details that need attention while working on an eCopy are:
Follow the recommended naming convention.
Ensure each pdf is within 50 MB.
Hardcopy should be an exact duplicate of the copy.
Ensure there is a separate printed cover letter for eCopy.
Send the eCopy on a CD/DVD/Flash drive.
The cover letter should be enclosed with an eCopy statement.
More than 1 CD is not allowed, if the data exceeds the capacity of the CD, then the copy should ideally be sent on a pen drive.
For further details on eCopy and its submission guidance, do write to us at [email protected] or check our complete guide - eCopy Medical Device Submission (How to create a successful eCopy?)
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Document-Capture Leader Nuance Reportedly Buys Notable Solutions
Document-Capture Leader Nuance Reportedly Buys Notable Solutions
Although no public announcement has been made, according to the Document Imaging Report, Nuance Communications has purchased Notable Solutions, Nuance’s primary competitor in the document-capture market.
In the digital-imaging world, Nuance, based in Burlington, Vermont, is best known for its eCopy, a scanning and OCR solution for scanning, processing, and automating paper-based…
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Another Canduits library started, release in the next month
So I've been a bit quiet, but I've been busy! Got another Canduits library coming soon and will be looking to build more in the coming months. First thing, a new connector works release that makes use of the Canduits modules! Stay tuned
Scan to iPad, iPhone, (iOS), Android, Windows Phone 7, Blackberry and virtually any mobile platform
We get a lot of questions about mobile devices. People want to see their scanned documents on their mobile devices.
Tablets are taking centre stage now with the impressive and explosive growth of the iPad, the groundbreaking Ice Cream Sandwich from Android, and the newly demonstrated Windows 8 platform (more on that shortly).
Mobile phones are transforming into smart phone devices, screens are getting larger and capabilities are increasing.
So how can we help with that?
Three of our connectors already allow you to scan to mobile devices. We use the Dropbox connector frequently to view our scanned documents on the iPad thanks to the Dropbox iOS app. Box.Net provides a similar experience as does Google Docs from any web browser.
The technology exists now. Using these incredible technologies you can scan to any of these platforms with our connectors and get access to your important documents on the go. We can even implement technologies these in your existing connectors.
