Siemens aims to simplify compliance for Linux medical devices
Siemens Digital Industries Software had released a documentation package for developers of medical devices that are using its embedded Linux distributions, Sokol Flex OS and Sokol Omni OS.
The Siemens Quality Package primarily targets safety and cybersecurity requirements for device development. Relevant guidelines are captured and mapped to UL 2900, the standard for network-connected devices. The package supports test plans and necessary results traceability.
Sokol family development can be mapped to other important standards for medical devices. These include ISO 13485 (lifecycle and quality risk management) and IEC 62304 (functional safety standard covering safe design and maintenance of software) standards.
Compliance processes for medical devices featuring embedded technology have already been set by both the European Union and the US Food and Drug Administration.
Scot Morrison, vice president and general manager for Embedded Platform Solutions at Siemens DIS says the Quality Package makes the company “the industry’s first provider of comprehensive software documentation for an embedded Linux distribution targeting the medical device market”.
The package is available now.
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