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How can Processor Expert code be used in medical devices?

Question asked by Charles Palmer on Dec 27, 2014
Latest reply on Feb 5, 2015 by Marek Neuzil

European and US regulators of medical devices both mandate the use of the IEC 62304 standard “Medical Device – Software Life Cycle Processes” which requires the design of a software quality process. Third party software that is incorporated into products is referred to as "SOUP" - software of unknown provenance - and requires an evaluation process before such software can be included in medical devices. I think that Processor Expert code, and the FreeRTOS component available as a PE component, will be SOUP.

 

Freescale clearly targets the medical devices industry. What assistance can you provide to medical device manufacturers who would like to use your chips and Processor Expert code, to address the SOUP problem?

 

A couple of links that provide background:

http://www.emdt.co.uk/article/developing-medical-device-software-iso-62304

http://medicaldesign.com/prototyping/industry-viewpoint-device-makers-can-take-cots-only-clear-soup

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