First Test Facilities, Products Recognized Under New IEEE Cybersecurity Certification Program

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

By submitting medical devices for IEEE certification, manufacturers demonstrate conformity with the IEEE 2621 standard. Such conformity may help expedite the regulatory product approval process.

“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.”

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. “We’re particularly proud of this achievement because it follows the successful completion of two pilot projects that used the IEEE 2621 standard for medical device testing. These projects allowed us to refine our processes and demonstrate our expertise in applying this standard,” added Rasma Mozuraite Araby, CEO of atsec AB in Stockholm, Sweden.

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.

IEEE Standards Association (IEEE SA) is a collaborative organization where innovators raise the world’s standards for technology. IEEE SA provides a globally open, consensus-building environment and platform that empowers people to work together in the development of market-relevant technology standards, and industry solutions shaping a better, safer and sustainable world. 

IEEE is the world’s largest technical professional organization dedicated to advancing technology for the benefit of humanity. Through its publications, conferences, technology standards, and professional and educational activities, IEEE is the trusted voice in a wide variety of areas ranging from aerospace systems, computers, and telecommunications to biomedical engineering, electric power, and consumer electronics.