FDA Release Final Rule on Unique Device Identifiers (UDI)

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The Food and Drug Administration (FDA) has released a final rule requiring that most medical devices distributed in the United States carry a unique device identifier, or UDI. It also applies to certain combination products that contain devices and to devices licensed under the Public Health Service (PHS) Act (e.g., donor screening assays).

A UDI system has the potential to improve the quality of information in medical device adverse event reports, which will help the FDA identify product problems more quickly, better target recalls and improve patient safety. In developing the proposed UDI system, the FDA worked closely with industry, the clinical community and patient and consumer groups, and conducted four pilot studies.

For more information, review the full article on the FDA’s web site:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm?utm_source=Members-Only Updates

Portford’s own DocuNECT Medical Device Tracking system is completely flexible when it comes to assigning device IDs and can fully support the UDI guidelines as outlined by the FDA.

If you use our Medical Device Tracking solution and want to find out more information then don’t hesitate to reach out to us at: support@portfordsolutions.com.

Using DocuNECT to Capture Email

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Email can be a very effective document capture method because it provides a familiar interface for customers and/or vendors to send documents directly into a document management process. DocuNECT provides three key benefits/features that can help automate this process:

1. Manage / Filter your E Mails – DocuNECT can filter documents based on business rules so you can make sure that only documents you are expecting make it to your document management system.
2. Combine Attachments / PDF Rendering – DocuNECT can render multiple email attachments in different formats to one PDF format. The email body can either be placed at the front or the back of the PDF document. This allows the email and associated attachments to delivered to the document management system as one document.
3. Extract Data – DocuNECT’s data extraction engine can be use to extract information from the email body or any of the attachments for auto-indexing of the documents.

DocuNECT – A Turn-Key Document Management Solution for Financial Services

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Easy to use and attractively priced, DocuNECT is the perfect choice to achieve great results on a tight budget.

Electronic document capture and management solutions can help Banks, Credit Unions and Mortgage Companies centrally control their documentation creating scalable and cost effective operations.

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