國內外智慧醫材法規文件
- 41 General Principles of Software Validation: Guidance for Industry and FDA Staff, 2002.
- 42 (EU)General leaflet ATI Policy Brief reports, 2021
- 43 (IMDRF)Machine Learning-enabled Medical Devices - A subset of Artificial Intelligence-enabled Medical Devices Key Terms and Definitions, 2021
- 44 MHRA Guidance: Medical Device stand-alone software including apps (including IVDMDs)
- 45 IMDRF/SaMD WG/N41FINAL, “Software as a Medical Device (SaMD): Clinical Evaluation”
- 46 醫療器材網路安全之業者揭露聲明書_植入式心律器之脈搏產生器(發布日期:2021-12-06)
- 47 醫用軟體分類分級參考指引(發布日期:2022年9月15日)
- 48 Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k)) Submissions, 2020
- 49 Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act - Guidance for Industry and Food and Drug Administration Staff, 2019.
- 50 (EU)proposal-for-a-regulation-laying-down-harmonised-rules-on-artificial-intelligence-impact-on-the-healthcare-sector-and-the-medical-device-industry, 2021