'ISO 14971: medical devices - application of risk management to medical devices' (Healthcare Technologies, 2018), 'Engineering High Quality Medical Software: Regulations, standards, methodologies and tools for certification', Chap. 6, pp. 69-85, DOI: 10.1049/PBHE012E_ch6 IET Digital Library, https://digital-library.theiet.org/;jsessionid=6c12102ugjq2.x-iet-live-01content/books/10.1049/pbhe012e_ch6