References

GIRJAESOFT Medical Device References

[FDA CS-POST:2016]Postmarket Management of Cybersecurity in Medical Devices, FDA, 2016.12.28

[FDA CS-PRE:2025]Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, FDA, 2025.06.27

[FDA DI:2016]Data Integrity and Compliance With CGMP Guidance for Industry Draft Guidance, FDA, 2016

[IEC 60601-1-6:2013]Medical electrical equipment - Part1-6 General requirements for basic safety and essential performance

[IEC 60601-1:2012]Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

[IEC 62304:2015]Medical device software - Software life cycle processes, 2015

[IEC 62366-1:2015]Medical devices - Application of usability engineering to medical devices

[ISO 13485:2016]Medical devices - Quality management systems, 2016

[ISO 14971:2012]Medical devices - Application of risk management to medical devices, 2012

[ISO 15223-1:2012]Symbols to be used with medical device labels, labelling and information to be supplied, 2012

[ISO/IEC 27000:2018]Information technology — Security techniques — Information security management systems — Overview and vocabulary, 2018

[MDFS CS-G:2024]의료기기의 사이버보안 허가,심사 가이드라인 [민원인 안내서], 식품의약안전처, 2024.11.27.

[MDFS DTX-G:2020]디지털치료기기 허가·심사 가이드라인(민원인 안내서),식품의약품안전처, 2020.08

[MDFS EP-G:2017]의료기기 위험관리 가이드라인 공통기준규격 실무안내서 - 필수성능, 식품의약품안전처, 2017.12

[MDFS PEMS-G:2017]의료기기 위험관리 가이드라인 공통기준규격 실무안내서 - 프로그램가능 의료용 전기시스템(PEMS), 식품의약품안전처, 2007

[MDFS RM-G:2007]의료기기 위험관리 가이드라인, 식품의약품안전처, 2007

[MDFS RM-G:2017]의료기기의 전기∙기계적 안전에 관한 공통기준규격 실무안내서 - 위험관리, 식품의약품안전처, 2007.12

[MDFS SV-G:2007]의료기기 소프트웨어 밸리데이션 가이드라인, 식품의약품안전처, 2007

[MDFS USE-G:2017]의료기기 위험관리 가이드라인 공통기준규격 실무안내서 - 사용적합성, 식품의약품안전처, 2017.12

[MDFS USE-G:2023]의료기기 GMP 기준 중 사용적합성 GMP 기준 중 사용적합성 적용 가이드라인적용 가이드라인(민원인 안내서), 식품의약품안전처, 2023.12

[RUP]Rational Unified Process: Best Practices for Software Development Teams

[SCMTREE]Brad Appleton et. al., Streamed Lines: Branching Patterns for Parallel Software Development, PLoP '98 Conference, 1998