Can I read SaMD Clinical Evaluation Guidance N41 on EtoBox?
SaMD Clinical Evaluation Guidance N41 by ErnestoAlcoleaGonzález is a document available to read on EtoBox.
What is SaMD Clinical Evaluation Guidance N41 about?
The document provides guidance for planning the clinical evaluation of software as a medical device (SaMD). It recommends a three-step process: 1) demonstrate a valid clinical association between the SaMD output and condition, 2) validate that the SaMD accurately processes input data, and 3) validate the SaMD
- Author
- ErnestoAlcoleaGonzález
- Language
- EN