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aug 5, 2016 - IMDRF: Software as a Medical Device (SaMD): Clinical Evaluation

Description:

This document provide guidance on clinical evaluation describing relevant clinical evaluation methods and processes, necessary level of clinical evidence for different categories of SaMD, and SaMd categories where independent review is important and not important.

Added to timeline:

8 months ago
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SAMD Timeline

Date:

aug 5, 2016
Now
~ 2 years and 3 months ago
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