Summary: Mindray North America has achieved UL 2900-2-1 certification for its BeneVision N12, N15, and N17 patient monitors, highlighting its commitment to cybersecurity and industry standards.

Key Takeaways:

  • Mindray’s BeneVision patient monitors are the first medical devices from China to achieve UL 2900-2-1 certification, emphasizing their cybersecurity robustness.
  • The certification aligns with the NIST cybersecurity framework and FDA standards, enhancing Mindray’s reputation for secure and reliable medical devices.

Mindray North America announced a new strategic certification that aligns with its secure by design approach to cybersecurity. Its flagship patient monitoring offering, the BeneVision N12, N15, and N17 monitors have obtained the UL Solutions Cybersecurity Assurance Program (CAP) certification to UL 2900-2-1.

According to Mindray, they are the first medical devices manufactured in China to achieve this certification. UL Solutions is a global safety science leader in independent third-party testing, inspection, and certification services and related software and advisory offerings.

Comprehensive Approach to Cybersecurity

“Driven by challenges with cybersecurity in healthcare today, Mindray looked to a more comprehensive approach to third-party assessment of the entire product lifecycle,” said Frank Menzel, Program Director of System Solutions at Mindray North America. “The vision was for a process-driven cybersecurity certification embedded within the Mindray development culture.”

Importance of UL 2900-2-1 Certification

The UL 2900-2-1 certification assesses the security of products and systems that connect to networks, along with the processes used by vendors to develop and maintain these products, with a strong emphasis on security. UL Solutions CAP offers a comprehensive range of solutions aimed at assisting organizations in handling cybersecurity risks and demonstrating their cybersecurity capabilities to the market.

Commitment to Cybersecurity

Receiving this certification is meant to underscore Mindray’s commitment to demonstrating its products meet or exceed industry-standard cybersecurity measures.

“Mindray is excited about the combination of device testing and a secure by design process validation backed by the UL Solutions certification while also aligning with the NIST cybersecurity framework and UL 2900-2-1 being an FDA consensus standard for medical device cybersecurity,” said Menzel.

Mindray’s BeneVision N12, N15, and N17 patient monitors empower healthcare providers by offering a premier solution to satisfy patient monitoring needs across diverse care settings, including OR, ICU, NICU, and ER/Trauma. With a platform-wide modular design, expansive parameter options, and specialized Clinical Assistance Applications (CAAs), the N12, N15, and N17 patient monitors support clinical excellence and align nicely with organizational cost of ownership goals.