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 the device.
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
Document issued on: May 11, 2005
Verification and Validation
In a software development environment, software verification is confirmation that the output of a particular phase of development meets all of the input requirements for that phase.
Software validation refers to establishing, by objective evidence, that the software conforms with the user needs and intended uses of the device.
Planning, verification, traceability, configuration management, and many other aspects of good software engineering are important activities that together help to support a conclusion that software is validated.
IEC/ISO
IEC 62304: Medical device software – Software life cycle processes
Edition 1.1 2015-06
1.2 Field of application
This standard does not cover validation and final release of the MEDICAL DEVICE, even when the MEDICAL DEVICE consists entirely of software.
NOTE 3 Validation and other development activities are needed at the system level before the software and medical device can be placed into service. These system activities are not covered by this standard, but can be found in related product standards (e.g., IEC 60601-1, IEC 82304-1, etc.).
3.33 VERIFICATION
In design and development, VERIFICATION concerns the PROCESS of examining the result of a given ACTIVITY to determine conformity with the stated requirement for that ACTIVITY.
ISTQB EXAM CERTIFICATION
Verification makes sure that the product is designed to deliver all functionality to the customer.
It answers the questions like: Am I building the product right?
It is a Low level activity
Validation is determining if the system complies with the requirements and performs functions for which it is intended and meets the organization’s goals and user needs.
It answers the question like: Am I building the right product?
It is a High level activity.
식품의약품안전처
2015.7
6.1 의료기기 소프트웨어 첨부자료 요구사항
의료기기 허가·심사 시 주요 검토 문서로는 소프트웨어 설계 명세서(SDS, Software Design Specification), 소프트웨어 요구사항 명세서(SRS, Software Requirement Specification) 및 이를 확인할 수 있는 검증 및 유효성확인 보고서(V&V, Verification & Validation) 등이 해당된다.
정리
용어 정의
- 검증(verification): 개발 단계별 결과물이 해당 단계의 입력 요구사항을 충족시킨다는 객관적인 증거를 제시하는 작업
- 유효성확인(validation): 최종 결과물이 사용자의 필요와 의도된 사용에 부합함을 확인하는 작업
사용 예시
- 의료기기 개발 전 과정(기획, 구현, 배포, 폐기)에서 검증을 수행합니다.
- 객관적인 증거를 마련하여 검증을 수행합니다.
- 테스트는 검증 활동의 한 가지 유형입니다.
- 다양한 검증 활동을 수행함으로써 최종 결과물에 대하여 유효성확인을 할 수 있습니다.
- 제조사의 경험과 지식에 따라 유효성확인을 하는 자신감의 수준이 달라집니다.
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