Medical Device Manufacturer Questions

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1. As a manufacturer of medically implantable devices, why should I choose   to include Q Inside Safety Technology in my device?

  1. VeriTeQ's Q Inside Safety Technology is the only FDA cleared Unique Device Identification (UDI) device on the market that can give an implantable medical device manufacturer and healthcare provider the ability to retrieve UDI information about an implantable medical device in vivo, on demand, at the point of care, from outside the body. Currently, VeriTeQ knows of no other companies that can offer this type of solution to the medical device community.
  2. Q Inside Safety Technology Provides Manufacturers Brand Quality and Product Verification to patients and physicians and provides anti-counterfeiting protection.
  3. Incorporating Q Inside Safety Technology into your medical devices could play an important role in inventory management, distribution and workflow management at the manufacturing level as well as at the physician and hospital level
  4. As a medical device manufacturer, devices that include Q Inside Safety Technology keep you connected to your patients and surgeons/ customers and can provide post-surgical analytical data that is vital to your business.
  5. Most medical device manufacturers include product or warranty cards with their medical devices for surgeons to give to their patients. However, most patients will either lose or misplace these paper based materials, surgeons and hospitals may or may not keep this data on a per patient basis and if so it may be very difficult and time consuming for a patient to gain access to their device data if and when needed. Q Inside Safety Technology can never be lost. In the event that a device recall or issuance of an adverse event report, device specific information can be accessed by a healthcare practitioner that has the VeriTeQ hand held reader which can be used to verify the device information of a medical device implanted in a patient.

2. What type of FDA clearance does VeriTeQ have?

In October 2004, VeriTeQ 's implantable RFID technology was cleared by the U.S. Food and Drug Administration (FDA) for medical use in the United States (as a Class II Medical Device). In fact, VeriTeQ's implantable micro-transponder, known as Q Inside Safety Technology, is considered a "predicate device" within the FDA, meaning other companies or manufacturers wishing to enter the industry will be measured against this device. VeriTeQ's radiation dosimetry technologies also have FDA clearance and CE marks.

3. What types of implantable medical devices can Q Inside Safety Technology be used with?

Q Inside Safety Technology, in its current form, can be embedded into breast implants, artificial hips, knees, shoulders, vascular ports, and traumatic fracture repair devices just to name a few. If you would like to explore how VeriTeQ can implement Q Inside Safety Technology into your device please contact us at sales@veriteqcorp.com or call our business development team at 561-846-7005.

4. How does Q Inside Safety Technology compare to other forms of UDI technology on the market?

While other forms of UDI technology such as bar coding systems, labeling systems, RFID systems, etching systems, etc., can be used to help medical device manufacturers (manufacturers of both implantable and non-implantable medical devices) and healthcare providers meet the FDA's UDI requirements, these technologies are typically used to identify medical devices from outside of the body. Once an implantable medical device is separated from its packaging and surgically implanted into a human, the UDI information on the packaging of the device may no longer be readable or easily accessible.

VeriTeQ's technology enables healthcare practitioners to retrieve UDI information about an implantable medical device, in vivo, on demand, at the point of care. VeriTeQ believes that it is the only company that can currently offer implantable medical device manufacturers and healthcare providers the ability to retrieve UDI information from an implantable medical device, in vivo, at the point of care