meddev-samd-clinical-evaluation
Guide Software as a Medical Device (SaMD) and software in devices for clinical evaluation expectations: intended use, SaMD category (IMDRF framework), evidence of analytical and clinical validity where applicable, and alignment with EU MDR Annex XIV clinical evaluation and FDA premarket clinical/benefit-risk expectations for software-driven diagnostics and monitoring. Use when working on samd clinical evaluation in medical device software.
- Version
- 1.0.0
- License
- MIT
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