Helping You Meet Your Compliance Needs and Beyond...

We understand the risks and challenges of meeting FDA Regulations. Count on MedDevTrack to provide the most up-to-date solutions to help you meet and exceed FDA UDI and other Regulatory requirements.

The Risks...

  • Class III
  • Recalls

An alarming number of new medical devices have been recalled in the previous few years. Can you identify all the physicians and patients who have been involved with your device to contact them in case of a serious recall? What is your regulatory exposure to non-compliance and lack of information?

The Challenges...

  • 1-49
  • 50-249
  • 250

Changing Government Regulations are the biggest challenge facing the Medical Device according to most industry polls.  What is the full expectation of providing the right solutions to meet the regulations in a global marketplace? How best to protect your IP and patient information

The Solution...

Screen Shot 2016-03-18 at 9.46.14 AM

Tracking Medical Devices is the key to meeting both UDI regulatory compliance and to be able to deliver the best practice for patient safety and help you gain an understanding of what is happening with your device in a the clinical domain that includes the whole of the patient marketplace for your device.

FDA Regulation Deadlines Are Here!

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

Medical Device manufacturers are required by the FDA to track certain types of devices from manufacture through the distribution chain to patients. The FDA released 21 CFR Part 821, which governs the requirements around the tracking process.  MedDevTrack was designed for exactly this purpose.

The Regulations…

This is an evolving space and we are writing a series of articles to you help you navigate through the regulation changes:

Webinar Recording: Tracking Medical Devices – How to Manage UDI Compliance Readiness (11/19/2015)

Rapidly Changing USA and Worldwide Regulatory Environment (7/26/2015)

Medical Device Tracking – The Next Generation (5/19/2015)

How Can We Help?

MedDevTrack provides software, services, consulting, and support to help make this process as painless as possible:

  • 21 CFR Part 821 Compliant Workflow Solution
  • Automated Correspondence
  • Automated E-mail/Faxing
  • Document and Image Management
  • 21 CFR Part 11 Electronic Signatures
  • Patient Data Management (HIPAA Compliant)
  • Dashboard and Management Reporting
  • Technology Transition
  • Device Disposition Audits
  • Managed Services

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.