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IMDRF/SaMD WG/N41FINAL:2017 Software as a Medical Device (SaMD) Clinical Evaluation - PDF (1.10Mb)

赵静曼 6/19/2022 浏览 252 IMDRF/SaMD WG/N41 世界

标准简介

Software as a Medical Device (SaMD) Clinical Evaluation - PDF (1.10Mb)[附网盘链接]是于21 September 2017发布的GHTF标准，适用于世界。

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Software as a Medical Device (SaMD) Clinical Evaluation - PDF (1.10Mb)[附网盘链接]
Software as a Medical Device (SaMD) Clinical Evaluation - PDF (1.10Mb)[附网盘链接](截图)

 

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标准部分原文

_____________________________________________________________________________________________

3.0 Introduction

The International Medical Device Regulators Forum (IMDRF) seeks to establish a common and

converged understanding of clinical evaluation and principles for demonstrating the safety,

effectiveness and performance of SaMD.

As illustrated in Figure 4, this document represents a global harmonization effort to articulate

this process.

Clinical Evaluation

Analytical Validation Clinical Validation

Valid Clinical Association

Does use of your SaMD’s

Is there a valid clinical

Does your SaMD correctly

accurate, reliable, and precise

association between your

process input data to generate

output data achieve your intended

SaMD output and your

accurate, reliable, and precise

purpose in your target population

SaMD’s targeted clinical

output data?

in the context of clinical care?

condition?

Figure 4- Clinical Evaluation Process

The document further explains that:

 Clinical evaluation should be an iterative and continuous process as part of the quality

[3]

management system for medical devices (See SaMD N23 for more information);

 Certain SaMD may require independent review of the results of the clinical evaluation,

akin to peer review or design review, to ensure that the SaMD is clinically meaningful to

users. The level of evaluation and independent review should be commensurate with the

[2]

risk posed by the specific SaMD (See SaMD N12 for more information); and

 Software is unique in its level of connectivity, which may allow the continuous

monitoring of the safety, effectiveness, and performance of SaMD. This document

encourages manufacturers to use this feature to understand and modify software based

on real-world performance. (See 9.0 Pathway for Continuous Learning Leveraging Real

World Performance Data for more information).

Healthcare decisions increasingly rely on information provided by the output of SaMD where

these decisions can impact clinical outcomes and patient care. As such, global regulators expect

that performance metrics for a SaMD have a scientific level of rigor that is commensurate with

the risk and impact of the SaMD to demonstrate assurance of safety, effectiveness, and

performance.

21 September 2017 Page 7 of 30

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