검증(Verification)과 유효성확인(Validation) 의료기기 소프트웨어 허가·심사 및 품질 관리와 관련하여 중요하게 사용하는 용어임에도 불구하고 그 의미를 구분하기가 쉽지 않아서 정리해 보았습니다. FDA Guidances General Principles of Software Validation; Final Guidance for Industry and FDA Staff Document issued on: January 11, 2002 3.1.2 Verification and Validation Software verification provides objective evidence that the design outputs of a particular phase of the software development life cycle meet all of the specified requirements for that phase . FDA considers software validation to be “confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses , and that the particular requirements implemented through software can be consistently fulfilled.” In large measure, software validation is a matter of developing a “ level of confidence ” that the device meets all requirements and user expectations for the software automated functions and features of th...