Medical Device & Patient Tracking Solutions
Outsourced Device Tracking for Medical Device Manufacturers
The FDA’s medical device tracking requirement 21 CFR Part 821 requires that manufacturers of certain devices establish and maintain a written standard operating procedure related to tracking devices, quality control, and audit procedures. In this highly regulated environment, document control, document management and ongoing, scheduled device follow-up procedures are critical for compliance.
TRaC II – A Digital Tracking Solution
The Scantron TRaC II Digital Solution has been designed to meet the requirements for medical device tracking in compliance with 21 CFR Part 821. Click here to learn more>>
