Siemens has introduced a software documentation package to help manufacturers streamline compliance with standards for medical devices.

The package is aimed at manufacturers deploying either of Siemens’ embedded Linux distributions – Sokol Flex OS or Sokol Omni OS.

The open-source Linux operating system (OS) is the world’s most widely used embedded OS according to analyst firm VDC Research, and suitable for many medical applications due to its customisability, high levels of security, graphics, robust networking capabilities and broad availability of embedded tools.

However, many electronic and connected medical device OEMs today must meet standards established by the EU and the US FDA, requiring time consuming product compliance approval documentation that outlines the product’s risk analysis and cyber-security management features, as well as all software requirements, architecture and maintenance information.

Siemens’ Quality Package for embedded Linux is an add-on to the company’s Sokol Flex OS and Sokol Omni OS embedded Linux distributions. The offering captures critical information necessary to achieve regulatory approval for safety and cyber-security 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 offering to provide OS and board support package test plans and corresponding test results for traceability.

Siemens’ embedded development processes are also mapped to a range of other standards including ISO 13485 for lifecycle and quality risk management and the IEC 62304 functional safety standard covering safe design and maintenance of software.

To help users save time, improve product quality and meet faster regulatory compliance, the package 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 at Siemens Digital Industries Software. “Our expertise in embedded development platforms, runtime, as well as open-source software and services, can help OEMs mitigate the risks they face in developing next-generation medical devices.”

Siemens Digital Industries Software helps organisations of all sizes digitally transform using software, hardware and services from the Siemens Xcelerator business platform. Siemens’ software and digital twin technology help companies optimise their design, engineering and manufacturing processes to turn ideas into sustainable products.