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. Here’s how Scantron’s TRaC II Digital Solution helps companies address challenges that are common to the implementation and management of these processes:

Medical Device Tracking Challenges

    Inefficient Patient Tracking
  • Inadequate tracking when patients move
  • High lost to follow-up ratio
    Disparate Systems
  • Multiple systems
  • Multiple formats
    Reporting – Access & Systems
  • Foraging multiple systems can be costly and time consuming when developing and preparing reports/li>
    Inconsistent Data
  • Data integrity and accuracy issues frequently arise when following manual processes
    System Development
  • Costly custom development and implementation
  • Limited IT resource availability

Scantron TRaC II Tracking Solution

    Dynamic Patient Tracking
  • Consistent, ongoing patient tracking
  • Less than 1% lost to follow-up ratio
    Smarter Technology
  • One centralized system
  • Time-stamped audit trail
    EDI & Online Access
  • Integrates with other applications
  • Secure data access for statistical analysis
    Quality Assurance
  • Automated validation checks, certification training, and audit team ensure the accuracy and relevancy of all data
    TRaC II System
  • Aids FDA compliance
  • System Ready. Simply import, validate and integrate