RT Chapter SR Electronic(1) YR 2018 T1 ISO 13485: medical devices - quality management systems - requirements for regulatory purposes T2 Engineering High Quality Medical Software: Regulations, standards, methodologies and tools for certification PB Institution of Engineering and Technology JF Healthcare Technologies SN 9781785612480 DO 10.1049/PBHE012E_ch5 UL https://digital-library.theiet.org/;jsessionid=5gstp1ghcs57s.x-iet-live-01content/books/10.1049/pbhe012e_ch5