Medical Device Manufacturers

The World Health Organization describes medical devices as any:

  • Instrument
  • Apparatus
  • Implement
  • Machine
  • Appliance
  • Implant
  • Reagent for in vitro use
  • Software
  • Material or other similar or related article, intended by the manufacturer to be used, alone or in combination for a medical purpose

Devices undoubtedly improve quality-of-life and longevity for millions of individuals every year.  Today, an estimated 2 million different kinds of medical devices are on the world market, categorized into more than 7000 generic device groups.

With so many current and future innovations being implanted into patients, it is important to conquer the final mile of device traceability!

You are not alone in being overwhelmed in the daunting effort to constantly update an independent database of contact information for distributors, final/multiple distributors, providers, and patients.  Speaking to a wide array of manufacturers, “Brute Force” is a commonly used phrase when addressing internal manual processes to communicate important information such as recalls or field notices.

When a recall or field notice becomes necessary, there could be a significant negative impact to your brand as well as costly legal ramifications if not handled properly. Primary factors to the success of a recall are the speed of notification and accuracy of data pertaining to everyone associated to those devices. Patients as well as purchasers of the device must be notified immediately to avoid potential adverse events. Incomplete records of purchasers, providers, and patients make contacting these parties nearly impossible. Moreover, even if you initially received contact information, it may be out-of-date. As a result, you face a serious risk of failing to notify many interested parties when initiating a recall.

People crazy enough to think they can change the world actually do.

Change the world and we'll support the regulatory and communication aspects of innovation.
Complimentary Medical Device Manufacturer FAQ