'FDA title 21 of US CFR' (Healthcare Technologies, 2018), 'Engineering High Quality Medical Software: Regulations, standards, methodologies and tools for certification', Chap. 3, pp. 31-42, DOI: 10.1049/PBHE012E_ch3
IET Digital Library, https://digital-library.theiet.org/;jsessionid=1ypd3xaigyyvd.x-iet-live-01content/books/10.1049/pbhe012e_ch3