Software Quality Assurance1
Paul S. Ganney · 2022
This chapter discusses quality issues regarding authoring software. Beginning with measurable attributes, documentation is considered (including in-code documentation techniques) along with version control. Automated testing is described before moving on to standards. IEC 601, DCB0129 and DCB 0160 are briefly considered and then the two European standards for medical devices (Medical Devices Directive and Medical Devices Regulations) are described in some detail, together with the current UK position following Brexit. CE marking is described and is followed by consideration of four other standards: IEC 62304-2015, IEC/ISO 90003-2004, ISO 13485-2003 and IEC 80001-1. Process standards relevant to the in-house production of medical software are listed. The chapter concludes with a brief consideration of coding standards and standards and guidelines issued by professional bodies.