Summary: The first medical devices, including those from Ascensia, have been certified under the new IEEE Medical Device Cybersecurity Certification Program, demonstrating conformity with international standards and ensuring cybersecurity for medical devices.

Key Takeaways: 

  • IEEE’s certification program helps manufacturers demonstrate cybersecurity conformity, potentially expediting regulatory approval processes.
  • Certified devices are listed on the IEEE certified product registry, ensuring safer and compliant products for users.

The first medical devices from companies including Ascensia have been certified under the new IEEE Medical Device Cybersecurity Certification Program. Test facilities from atsec in Sweden, Germany, and the United States have also been officially recognized under the program.

Certification Demonstrates Conformity

By submitting medical devices for IEEE certification, manufacturers can demonstrate conformity with an international standard. Having their devices evaluated against a rigorous test plan and checklists by IEEE authorized third-party test labs helps to ensure conformance with the IEEE 2621 standard. This may expedite the approval process by regulatory bodies.

IEEE’s Role

IEEE is a global technical professional organization dedicated to advancing technology for humanity, and the IEEE Standards Association (IEEE SA) launched the IEEE Medical Device Cybersecurity Certification Program in 2023. The program was developed by the IEEE 2621TM Conformity Assessment Committee (CAC), composed of stakeholders such as manufacturers, clinicians, the U.S. Food and Drug Administration (FDA), test laboratories, cybersecurity solutions providers, and industry associations from around the world. It aims to help address cybersecurity risks in medical devices that capture and manage user bio data and impact quality of life.

Atsec labs in Danderyd, Sweden, Munich, Germany, and Austin, Texas, are the first to be officially authorized to test medical devices under the IEEE Medical Device Cybersecurity Certification Program.

“We enthusiastically embraced the opportunity to become a player in this domain when IEEE first contacted atsec in July 2022,” said Sal La Pietra, President and co-founder of atsec information security.

Certified Devices

Several devices from Ascensia have successfully undergone the testing and certification process as outlined by IEEE. Certified products are listed on the IEEE certified product registry.

“The IEEE Standards Association offers a trusted global environment that enables expert technology communities to achieve meaningful impact at scale,” said Alpesh Shah, managing director, IEEE Standards Association. “The IEEE Medical Device Cybersecurity Certification Program is the most recent example, one that offers a standards-based pathway and process for medical device manufacturers to meet regulatory requirements globally and translate into safer, compliant products for users.”