Portford’s 21 CFR Part 821 compliant Medical Device Tracking solution is now available on the DocuNECT v4.8 platform.
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.