'Introduction' (Healthcare Technologies, 2018), 'Engineering High Quality Medical Software: Regulations, standards, methodologies and tools for certification', Chap. 1, pp. 1-15, DOI: 10.1049/PBHE012E_ch1 IET Digital Library, https://digital-library.theiet.org/;jsessionid=5vmt81lomj25.x-iet-live-01content/books/10.1049/pbhe012e_ch1