Siemens streamlines medical standards compliance for Linux OS based systems

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Siemens Digital Industries Software introduced the first software documentation package developed to help original equipment manufacturers (OEMs) streamline compliance with stringent standards for medical device manufacturers deploying either of Siemens’ embedded Linux distributions, Sokol Flex OS software or Sokol Omni OS software.

Siemens’ new Quality Package for embedded Linux is an add-on to the company’s Sokol Flex OS and Sokol Omni OS embedded Linux distributions. The new offering captures critical information necessary to achieve regulatory approval for safety and cybersecurity requirements.

Security guidelines are captured and mapped to UL 2900, which is the standard for network-connected devices, and other medical device specifications. This enables the new Siemens offering to provide OS and board support package test plans and corresponding test results for comprehensive traceability. Siemens’ embedded development processes are also mapped to a range of other standards including ISO 13485 (lifecycle and quality risk management) and IEC 62304 (functional safety standard covering safe design and maintenance of software). To help customers save time, improve product quality, and meet faster regulatory compliance, the Siemens’ Quality Package for embedded Linux also offers a sharable collection of documents accessible for pre- and post-manufacturing tasks.

“Siemens is the industry’s first provider of comprehensive software documentation for an embedded Linux distribution targeting the medical device market,” said Scot Morrison, vice president and general manager, Embedded Platform Solutions at Siemens Digital Industries Software. “Our expertise in embedded development platforms, runtime solutions, as well as open-source software and services, can help OEMs mitigate the risks they face in developing next-generation medical devices.”

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