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 Siemens’ embedded Linux distributions, Sokol Flex OS software, or Sokol Omni OS software.
The open-source Linux operating system (OS) is the world’s most widely used embedded OS according to analyst firm VDC Research and is well-suited for many medical applications due to its customizability, high levels of security, rich graphics, robust networking capabilities, and the broad availability of embedded tools. However, many electronic and connected medical device OEMs today must meet standards established by the European Union and the U.S. Food & Drug Administration (FDA), requiring time-consuming product compliance approval documentation that outlines the product’s risk analysis, cybersecurity management features, as well as all software requirements, architecture, and maintenance information.
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, Siemens’ Quality Package for embedded Linux also offers a sharable collection of documents accessible for pre- and post-manufacturing tasks.
Siemens’ Quality Package for embedded Linux is available today.