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