Organizations who have previously struggled with managing a recall internally, or perhaps do not have the time or resources to maintain the consignee data, develop a field strategy or create a centralized database, can trust Novasyte as their recall management partner.
Novasyte’s cloud-based S.M.A.R.T. Recall Program is an integrated, software and service-based solution that offers clients agility and flexibility with FDA recall, correction and removal support. Executing against the client’s recall strategy, Novasyte offers closed-loop support for all levels of field actions – from non-reportable actions to the most urgent Class 1 recalls.
Novasyte tracks, manages and measures every activity in real-time back to a unique identifier. The program also includes field-team deployment and the collection and warehousing of affected product, as needed.
The proprietary, integrated data platform safely, securely and confidentially tracks every activity in real-time. Activities include, but are not limited to:
- Notifications (written, phone and field)
- Digital signature capture
- Consignee acknowledgment
- Per-unit, serial number tracking
- Field-technician activities
- Product returns and RGAs
To learn more, request a personalized demonstration below.
If you're looking to improve the speed and accuracy of your next device recall, check out our latest white paper on "3 Steps to Improve the Accuracy and Speed of Your Next Medical Device Recall."
12. Legal Information Institute; Recall Status Reports. 21 C.F.R. § 7.53 (2017). Retrieved from https://www.law.cornell.edu/cfr/text/21/7.53