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
Hello Charles,
Could you please contact our Freescale Sales and Support team, please? See the page Sales and Support|Freescale
They are able to provide requested information about services and assistance.
Freescale quality certifications are available on the website Quality Certifications|Freescale
Best Regards,
Marek Neuzil