Medical Device Manufacturer Regulatory Compliance

Automate post-manufacture device tracking and alerting throughout a device’s entire useful life while ensuring compliance against federally regulated tracking provisions:

  • Section 519(e) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act)
  • 21 U.S.C. 360i(e)
    • Added in 1990 by the Safe Medical Devices Act (SMDA)
    • Amended in 1997 by the Food and Drug Administration Modernization Act (FDAMA).

When communication is necessary, our comprehensive services handle the logistics. We maintain contact with your patients and keep their ever-changing information updated. By sustaining device relationships to patients, you can immediately send thousands or millions of alerts within seconds, while also receiving acknowledgement of delivery and having access to comprehensive auditability.

Eliminating current manual processes, which rely heavily on paper and fax, and leveraging a seamless and automated solution embedded within existing workflows allows for the protection of brands, reduction of costs, avoidance of complications, ease of administrative burdens, improves patient satisfaction and safety, and complies with all device tracking and tracing requirements.

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.
Medical Device Manufacturer FAQ