2. 의료용 S/W 기술문서 심사 방법 2007-03-30 원 찬 요 유엘 코리아

3. 발표자 소개 -1998 년 2 월 한양대 전자공 졸업 -1987-11 ~ 1992-04: ㈜ 금성사 ( 현 LG 전자 ) 연구원 -1992-04 ~ 1999-06: ㈜ 메디슨 규격팀 팀장 -1999-07 ~ 2001-03: 원텍시험소 안전규격실장 -2001-05 ~ 2002-02: ㈜에이치엠티 프러덕트매니저 -2002-05 ~ 현재 : 유엘코리아, 의료기기사업부, 적합성평가부 * 현재업무 : FDA 510(k) 3 자기관, UL 마크 서비스 Reviewer, CE-Marking TCF Reviewer, CBTL Reviewer

4. 개정안 – 의료기기 소프트웨어에 관한 자료 “ 당해 제품에 소프트웨어가 내장되어 있거나 단독으로 사용되는 소프트웨어인 경우, - 소프트웨어의 형명 또는 명칭, - 버전, - 알고리즘, - 구조, - 주요 기능 및 기능표시화면, - 개발 환경 및 사용환경, - 위험분석, - 검증 및 유효성확인 등의 내용이 포함된 자료 ”

5. FDA’s Guidance Documents  Guidance for the content of premarket submissions for software contained in medical devices  Guidance for industry, general principles of software validation  Guidance for off-the-shelf software use in medical devices  Design control guidance for medical device manufacturers

6. 소프트웨어와 품질시스템  유럽  미국 IEC 60601-1-4 FDA’s Reviewers Guidance’s Quality System Regulation ISO 14971-1 SAFE MEDICAL DEVICES ACT MEDICAL DEVICES DIRECTIVE ONE SET OF DOCUMENTS ISO 13485

7. 적용범위  “ 당해 제품에 소프트웨어가 내장되어 있는 의료기기 ”  “ 단독으로 사용되는 소프트웨어 ”

8. Scope – “Software Device”  Firmware 및 의료기기의 소프트웨어 기반의 control 를 위한 기타 수단  독립적 (Stand-alone) 으로 사용되는 소프트웨어  일반 컴퓨터에 설치 (installation) 하여 사용할 수 있도록 설계된 소프트웨어  의료용 하드웨어 / 소프트웨어 기기  의료기기의 부속품 (accessory). 단, 부속품이 소프트웨어를 포함하거나 소프트웨어로 구성되어 있는 경우. “factory-installed”, installed by a third party vendor, or “field installed (by user)” Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

9. Scope – Exclusion  제조 혹은 공정 관리 기능을 위해 설계된 소프트웨어  GMP – “ 설계에서의 밸리데이션 (validation)” – “ 공정에서의 밸리데이션 (validation)” Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

10. FDA Consensus Standard  ISO 14971-1; Medical devices – Risk Management – Part 1: Application of risk analysis  AAMI SW68:2001; Medical device software – Software life cycle processes (Ref. IEC 62304) Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

11. 소프트웨어에 관한 자료 소소프트웨어의 형명 또는 명칭, 버버전 (Version, Revision History), 알알고리즘 (Algorithm in SRS), 구구조 (Architecture), 주주요 기능 및 기능표시화면 (SRS), 개개발 환경 및 사용환경 (Software Development Environment), 위위험분석 ( 위험요인분석 – Device Hazard Analysis), 검검증 및 유효성확인 (Verification & Validation)

12. FDA Software Documentation LL evel of Concern SS oftware Description DD evice Hazard Analysis SS oftware Requirement Specification (SRS) AA rchitecture Design – Software Architecture Specification (SAS) SS oftware Design Specification (SDS) TT raceability Analysis SS oftware Development Life-Cycle VV erification and Validation (V & V) Documentation RR evision History UU nresolved Anomalies (Bugs or Defects) Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

13. Level of Concern - Severity  Minor / Moderate / Major  Questionnaires - Rationale – Blood Establishment Computer Software – With Drug or Biologic – Accessory to Medical Device of (Major / Moderate) Level of Concern – Death or Serious Injury / Minor Injury Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

14. Software Description  Summary Overview of the features ( 개요 )  Software Operating Environment ( 운영환경 ) – Programming Language – Hardware Platform – Operating System (if applicable) – Use of Off-the-Self Software (if applicable) Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

15. Device Hazard Analysis  ISO 14971-1, Risk Management Summary  Hazards associated with device’s intended use, hardware & software. – Identification of Hazards ( 위험요인식별 ) – Severity of Hazards ( 심각도분석 ) – Cause of Hazards ( 원인분석 ) – Method of Control ( 통제방법 ) – Corrective Measures ( 위험경감 조치사항 ) – Validation ( 최종 확인 ) Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

16. SRS – Requirement Spec.  Hardware Requirements  Programming Language Requirements  Interface Requirements  Software Performance & Functional Requirements Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

17. SRS - Hardware  Microprocessor  Memory device  Sensor  Energy Source  Safety Feature  Communication Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

18. SRS – Programming Language  Program Size  Information on management of memory leaks Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

19. SRS - Interface  Printer  Monitor  Keyboard  Mouse Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

20. SRS – Performance & Function  Algorithm or Characteristics  Performance and Functional Requirements – Device limitation due to software – Internal software tests and checks – Error and Interrupt handling – Fault detection, tolerance, and recovery characteristics – Safety requirements – Timing and memory requirements – Identification of off-the-shelf software (if applicable) Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

21. Architecture  Flow chart or similar, showing: – Relationships among the major functional units in the “Software Device” – Relationships to hardware and to data flows such as networking  Maybe included in the SRS. Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

22. SDS – Design Spec.  Implementation & Details of SRS – Software Design Description (SDD), Functional Specification – SRS: What the Software Device will do – SDS: How the SRS are implemented Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

23. Traceability  Matrix showing: – Requirements – Specifications – Tests – Hazard Mitigation Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

24. Development Life-Cycle  Summary of Development Life-Cycle Plan – Defined Development Life-Cycle – Processes and Activities – Document List – Software Coding Standard (for Code Review)  Configuration (or Change) Management & Maintenance Plan – Definitive specifications – Life-Cycle – Test Plan Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

25. V & V Documents  V & V activities (lists) during Development Life-Cycle  System (Functional) Test (for minor/moderate level) Plan & Results  Unit / Integration / System Test (for major level) Plan & Results Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

26. Revision Level History  Revision History – Date – Version No. – Brief Description  Version No. System Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

27. Unsolved Bugs  For each anomaly: – Problem – Impact on device performance – Corrective Action Plan or Timeframe Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

28. Required Documents vs. Level of Concern  Documentation Based on Level of Concern DocumentationMinorModerateMajor Level of ConcernStatement & Rationale Software DescriptionOverview & Operating Environment Hazard AnalysisRisk Management Summary SRSSummary of Functions Complete SRS ArchitectureNoFunctional Units & Software Modules SDSNoSDS TraceabilityTraceability Analysis / Relationship Software Development Life-Cycle NoLife-Cycle (Summary of Configuration Management / Maintenance) Life-Cycle (Document list for each process, Coding Standard) (Plan of Configuration Management / Maintenance) V & V Function test V & V activities. System Level test V & V activities. Unit/Integration/System Level test Revision HistoryRevision Log & Release Version No. Unsolved BugsNoBugs or Defects / Explanation

29. Turn out the Lights The party’s over