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Industrial standards for developing medical device software providerequirements that conforming devices must meet. A number of reference softwarearchitectures have been proposed to develop such software. The ISO/IEC25010:2011 family of standards provides a comprehensive software productquality model, including characteristics that are highly desirable in medicaldevices. Furthermore, frameworks like 4+1 Views provide a robust framework todevelop the software architecture or high level design for any software,including for medical devices. However, the alignment between industrialstandards and reference architectures for medical device software, on one hand,and ISO/IEC 25010:2011 and 4+1 Views, on the other, is not well understood.This paper aims to explore how ISO/IEC 25010:2011 and 4+1 Views are supportedby current standards, namely ISO 13485:2016, ISO 14971:2012, IEC 62304:2006 andIEC 62366:2015, and current reference architectures for medical devicesoftware. We classified requirements from medical devices standards intoqualities from ISO/IEC 25010:2011 and architectural views from 4+1 Views. Asystematic literature review (SLR) method was followed to review currentreferences software architectures and a mapping of their support for theidentified ISO/IEC 25010:2011 qualities in the previous step was carried out.Our results show that ISO/IEC 25010:2011 qualities like functional suitability,portability, maintainability, usability, security, reliability andcompatibility are highly emphasised in medical device standards. Furthermore,we show that current reference architectures only partially support thesequalities. This paper can help medical device developers identify focus areasfor developing standards-compliant software. A wider study involvingunder-development medical devices can help improve the accuracy of our findingsin the future.

Assessing Support for Industry Standards in Reference Medical Software Architectures