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SaMD Framework.pdf

imdrf-tech-140918-samd-framework-risk-categorization-141013.pdf
Preview of SaMD Framework
🔗 Source: imdrf.org
📊 Size: 242 KB
👤 Author: IMDRF
⬇️ Downloads: 116

Summary

The International Medical Device Regulators Forum (IMDRF) published a document on "Software as a Medical Device": Possible Framework for Risk Categorization and Corresponding Considerations. The document provides a framework for categorizing software as a medical device (SaMD) based on its intended use, medical purpose, and potential risks. It outlines factors important for SaMD characterization, including the significance of information provided and healthcare situation or condition. The document also discusses general and specific considerations for SaMD, such as design and development, changes, socio-technical environment, technology and system environment, and information security.

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Description

The International Medical Device Regulators Forum (IMDRF) published a document on "Software as a Medical Device": Possible Framework for Risk Categorization...

Technical Information

  • File Format: PDF
  • File Size: 242 KB
  • Pages: 30
  • Language: EN
  • Author: IMDRF
  • Total Downloads: 116
  • Last Updated: 2 hours ago

Document Overview

This PDF document about SaMD Framework provides comprehensive information and guidance. Whether you're a beginner or advanced user, this resource offers valuable insights into SaMD Framework.

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