'IEC 62304: medical device software - software life-cycle processes' (Healthcare Technologies, 2018), 'Engineering High Quality Medical Software: Regulations, standards, methodologies and tools for certification', Chap. 7, pp. 87-93, DOI: 10.1049/PBHE012E_ch7
IET Digital Library, https://digital-library.theiet.org/;jsessionid=1jcdxtgjkezfk.x-iet-live-01content/books/10.1049/pbhe012e_ch7