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Software as a Medical Device (SaMD) | FDA
- https://www.fda.gov/medical-devices/digital-health-center-excellence/software-medical-device-samd
- Given the unique features of Software as a Medical Device that extend beyond a traditional medical device or hardware, regulators across the globe recognized the need to converge on a common framework and principles for Software as a Medical Device that enables all stakeholders, including regulators, to promote sa… See more
Good Machine Learning Practice for Medical Device …
- https://www.fda.gov/medical-devices/software-medical-device-samd/good-machine-learning-practice-medical-device-development-guiding-principles
- Multi-Disciplinary Expertise Is Leveraged Throughout the Total Product Life Cycle: In-depth …
Global Approach to Software as a Medical Device | FDA
- https://www.fda.gov/medical-devices/software-medical-device-samd/global-approach-software-medical-device
- The FDA issued the Software as a Medical Device: Clinical Evaluation final guidance to describe an internally agreed upon understanding of clinical evaluation and …
Good Machine Learning Practice for Medical Device …
- https://www.fda.gov/media/153486/download
- Good Software Engineering and Security Practices Are Implemented: Model design is implemented with attention to the “fundamentals”: good software engineering practices, …
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