Royal Philips (NYSE:PHG) announced today that it became the first medical device manufacturer to receive a new Underwriters Laboratories (UL) product cybersecurity testing certification. UL designed the UL IEC 62304 certification to provide a framework to evaluate the robustness and maturity of a medical device manufacturer’s cybersecurity controls and capabilities in product development, according to a […]
Underwriter's Laboratories
BD touts cybersecurity cred of its microbiology informatics software
Becton Dickinson (NYSE:BDX) announced that its BD Synapsys microbiology informatics solution received certification from the Underwriters Laboratory Cybersecurity Assurance Program (UL CAP). UL CAP is an independent program that uses standardized, testable criteria to assess software vulnerabilities and weaknesses. BD touts its BD Synapsys software as one of the first life-science diagnostics informatics platforms to meet […]
Underwriters Laboratories acquires British human factors firm Medical Device Usability
UL said today that it acquired Medical Device Usability, a British human factors services business, last month for an undisclosed amount. Cambridge, U.K.-based Medical Device Usability offers human factors services including user needs research, user interface design, formative and summative evaluation and preparation of human factors-related documentation and regulatory submission content. UL said it plans to […]
Underwriters Laboratories acquires Emergo Group
Global safety science company Underwriters Laboratories (UL) has acquired Emergo, a privately held firm that provides regulatory services and market access services to medical device manufacturers. The financial details of the acquisition were not disclosed. The acquisition, announced yesterday, combines UL’s range of services to support global regulatory approvals for the health sciences industry with […]
VA taps Underwriters Labs to secure medical devices
The Department of Veterans Affairs inked an agreement with testing and safety firm Underwriters Laboratories to help secure their connected medical devices from cyberattacks, according to a new report from Federal Computer Week. Read the full story at our sister site, Medical Design & Outsourcing.
UL provides medical device manufacturers alternative to traditional CFDA testing
UL, a global safety science organization, announced the launch of its new China Food and Drug Administration (CFDA) testing program for medical device manufacturers. This program allows medical device manufacturers outside of China the option to participate in and complete the required series of tests for CFDA approval at a local UL laboratory outside of […]
