Table of Contents Preface The document herein was produced by the International Medical Device Regulators Forum (IMDRF), a voluntary group of medical device regulators from around the world. The document has been subject to consultation throughout its development. There are no restrictions on the reproduction, distribution or use of this document; however, incorporation of this document, in part or in whole, into any other document, or its translation
The objective of the document is to provide guidance on the application of existing, standardized and generally accepted QMS practices to SaMD. This document starts from the perspective of a software development organization (of any size, i.e., could range from a one person enterprise up to a multi-national corporation) that incorporates the activities that are part of good software engineering and quality practices. The document gives an overview of these software quality activities and reinforces medical device quality principles that should be appropriately incorporated for an effective SaMD QMS. The purpose of this document is to: Inform the reader, who is assumed to already be following generally accepted software lifecycle processes, of SaMD specific practices. Create a bridge for software manufacturers who may not be familiar with medical device QMS and how software engineering and software quality practices may apply for SaMD. Provide guidance for the application of QMS for the governance of organizations responsible for delivering SaMD products and managing the SaMD lifecycle processes (product planning, risk management, document control and records, configuration management and control, measurement, analysis and improvement of processes and products, and managing outsourced processes and product) and SaMD lifecycle activities (requirements, designing, developing, deploying, maintaining and decommissioning). Highlight SaMD lifecycle activities through the lens of patient safety and clinical environment considerations, technology and systems environment considerations that should be addressed to ensure the safety, effectiveness and performance of SaMD. Help manufacturers and regulators attain a common understanding and vocabulary for the application of medical device quality management system requirements to SaMD. Complement the IMDRF SaMD framework for risk categorization and corresponding considerations This document is intended for the following audience: Groups and/or individuals who are or want to become developers of SaMD Software development organizations (large or small) that apply good software quality and engineering practices and that may not necessarily be familiar with medical device QMS requirements. Organizations (divisions/departments) working within established medical device quality systems that intend to communicate the linkage between medical device quality system practice and SaMD development practices. Document organization and content: Terminology used is intended to be familiar to the software industry and illustrates how typical software-engineering activities (e.g., determining requirements) translate to equivalent activities in a medical device quality management system (e.g., identifying ‘design inputs’) used in the management, design, development, implementation, monitoring and support of SaMD.