2025-01

The purpose of this document is to promote and inform clear and accurate characterizations of medical device software, including developing an intended use/intended purpose statement. Additionally, it aims to introduce a general strategy for characterizing software-specific risks, drawing upon the essential components of a comprehensive characterization of medical device software.

This document is intended to:

• highlight the importance of comprehensive characterizations for medical device software to inform additional lifecycle activities including risk assessment and device categorization/classification;
• establish key features of and common vocabulary for the characterization of medical device software;
• identify fundamental elements of an intended use/intended purpose statement for medical device software;
• establish links between characterization features and risk for medical device software; and
• provide information for consideration during the identification and assessment of software-specific risks of medical device software.

The document can be downloaded in our library

Source: IMDRF