Tracking Medical Devices and Managing Regulations

Count on MedDevTrack to provide the most up-to-date solutions to help you meet and exceed FDA UDI and other Regulatory requirements

Medical Device Tracking - Symposium Series

Device Tracking Features

FDA GUDID Integration

Seamless integration with the newly established FDA GUDID Webservice Database for delivery of unique, trackable device IDs

Cloud Based

Cloud-based device tracking workflow integrated with manufacturing, distribution and disposition

Imaging Integration

Industry-proven imaging repository
Image analysis for disposition into our workflow
PACS Compliance

Predictive Analytics

Seamless integration with the newly established FDA GUDID Webservice Database for delivery of unique, trackable device IDs

Government System Integration

Provide scaleability options for a subscription service to the newly defined FDA PMA reporting portal

Support Tracking

Electronic submission of required reports. Manage compliance to the Medical Device Reporting regulations supporting MedWatch form creation and submission to the FDA portal for reports.



Tracking Medical Devices and Managing Regulations

Event-driven workflow to track the disposition of multiple devices per event

  • Device Shipment
  • Receipt by the Sales Team or Hospital
  • Use in the Patient (Implanting)
  • Escalation (Explanting)
  • Patient Registration and tracking

Workflow Management System

  • Field Inventory
  • Automated follow up correspondence
  • Data and Document Capture
  • Customer contact and updates
  • Process compliance and Final QC with Electronic Signature
  • Device and Patient Reporting

Compliant and Validated Workflow

Ensures all follow ups are completed and all activities are recorded in a 21 CFR Part 11 compliant, human readable audit trail.

Automated Correspondence

There are a variety of correspondence types that are generated in the follow up process. This can be very time consuming and MedDevTrack will auto generate letters in an Adobe PDF format for your approval.

Automated E Mail/Faxing

Once you have approved the letter, it can automatically faxed or e mailed at the touch of a button.

Document and Image Management

All of these documents are kept in the central repository and are easily found with state of the art searching capabilities.

21 CFR Part 11 Electronic Signatures

Compliant, audited workflows, combined with built-in 21 CFR Part 11 electronic signature, provide a clear, accessible data set for regulatory needs.

Patient Data Management

Have the peace of mind that your patient data is secure, HIPAA/PIPEDA Compliant and that Patient Recall is easily processed.

Dashboard and Management Reporting

MedDevTrack provides real time utilization reporting for Management and Operations.

Device Disposition Audits

We can create your existing audit procedures or use our standard ones to ensure that you achieve the highest level of compliance.

Technology Transition

If you have data and documents in an existing system and need help to migrate to MedDevTrack, we are experts and provide full validation documentation.

Managed Services

We offer a complete managed service that combines a state-of-the-art cloud model with our call-center of trained device tracking specialists that will manage the entire process for you.

See How MedDevTrack Can Help You...

We offer a few options to allow you and your group to view our Medical Device Tracking system in action. Select a live, hosted demo, video playback or brochure presentation to begin the process of understanding our product and configuration options.