'ISO 13485: medical devices - quality management systems - requirements for regulatory purposes' (Healthcare Technologies, 2018), 'Engineering High Quality Medical Software: Regulations, standards, methodologies and tools for certification', Chap. 5, pp. 51-67, DOI: 10.1049/PBHE012E_ch5
IET Digital Library, https://digital-library.theiet.org/;jsessionid=w9dqdx9kwmkv.x-iet-live-01content/books/10.1049/pbhe012e_ch5