과제정보
This work was supported by the National Research Foundation of Korea(NRF) grant funded by the Korea government(MSIT) (No. NRF-2023R1A2C2003577) and the industry cooperation foundation fund, CHA University Grant (CHA-202201150001).
참고문헌
- International Medical Device Regulators Forum (2013, December 9) Software as a Medical Device (SaMD): Key Definitions, page 4, IMDRF/SaMD WG/N10[1]. Retrieved from https://www.imdrf.org/documents/software-medical-device-samd-key-definitions.
- International Organization for Standardization (ISO), IEC 62304:2006 Medical device software - Software life cycle processes.
- International Organization for Standardization (ISO), IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices.
- International Organization for Standardization (ISO), IEC 62366-2:2016 Medical devices - Part 2: Guidance on the application of usability engineering to medical devices.
- International Organization for Standardization (ISO), ISO 13485:2015 Medical Devices - Quality Management Systems.
- International Organization for Standardization (ISO), ISO 14971:2019 Medical devices - Application of risk management to medical devices.
- International Organization for Standardization (ISO), ISO/IEC 25010:2011 Systems and software engineering - Systems and software Quality Requirements and Evaluation (SQuaRE) - System and software quality models.
- International Organization for Standardization (ISO), ISO/IEC 25022:2016 Systems and software engineering - Systems and software quality requirements and evaluation (SQuaRE) - Measurement of quality in use.
- International Organization for Standardization (ISO), ISO/IEC 25023:2016 Systems and software engineering - Systems and software Quality Requirements and Evaluation (SQuaRE) - Measurement of system and software product quality.
- United States Food and Drug Administration (US FDA) (2017, December 6), What are examples of Software as a Medical Device? https://www.fda.gov/medical-devices/software-medical-device-samd/what-are-examples-software-medical-device Accessed February 6, 2023.
- United States Food and Drug Administration (US FDA) (2022, April 8), Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cybersecurity-medical-devices-quality-system-considerations-and-content-premarket-submissions Accessed April 12, 2023.
- United States Food and Drug Administration (US FDA) (2022, October 5), Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices. https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices Accessed February 6, 2023.