Siemens optimises compliance with medical standards
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.
The open-source Linux operating system (OS) is the world’s most widely used embedded OS according to analyst firm VDC Research, and well-suited for many medical applications due to its customizability, high levels of security, rich 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 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.
The 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.
The 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 offer provides 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.”