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Manufacturers are required to track the disposition of compliant devices from manufacturing, through distribution, implanting and patient monitoring. The purpose of device tracking is to ensure that manufacturers establish tracking systems that will enable them to promptly locate devices. Tracking information may be used to facilitate notifications and recalls ordered by the FDA in the case of serious risks to health presented by the devices. |
Portford's tracking solution is currently being used by device companies to manage the tracking/follow-up workflow defined by the Part 821 regulation. The solution is now available on Portford's new DocuNECT v4.8 platform.
DocuNECT v4.8 provides
the following benefits:
Enhanced
Web Service Integration Capabilities to make it even
easier to integrate DocuNECT with third party systems to validate
patient, physcian and device distribution data.
Enhanced
Management
Overview with dashboard, provding graphs and
reports on the current status of device disposition.
Performance
and Security Enhancements have been added to the product
to increase security and system response.
On
the technical side, the platform is now compatible with
the following technologies:
- Microsoft Server 2012
- Microsoft SQL Server 2012 SP1 and 2014 - The image viewer in DocuNECT Web now supports up to and including Java 8
- DocuNECT Web works with Microsoft Internet Explorer 11, Mozilla Firefox v29.0, and Google Chrome v35.0 - Client Tools is now compatible with Microsoft Windows v8.1
