IMDRF final document on applying a quality management system (QMS) to SaMD. It is aimed mainly at software development organizations that apply good software quality and engineering practices but may not be familiar with medical device QMS principles, and explains those principles from a software perspective. An effective QMS for SaMD is described in terms of three principles: leadership and organizational support, providing leadership, accountability, governance, and adequate resources to assure the safety, effectiveness, and performance of SaMD; SaMD lifecycle support processes, which are scalable for the size of the organization and applied consistently across all realization and use processes; and SaMD realization and use processes, covering activities from requirements through design, development, and verification and validation. The three principles are not separate series of processes: leadership and organizational support provides the foundation for the lifecycle support processes, which apply across the realization and use processes. The concepts in each section are related to clauses of ISO 13485:2003.

Information document of the IMDRF Management Committee listing how IEC 62304:2006 (Medical device software – Software life cycle processes) is used in each jurisdiction's regulatory system (as of 2015). In Australia, compliance is used as evidence of meeting the Essential Principles; in Canada and the US, it is a recognized standard that can be used as evidence of conformity or for a declaration of conformity. In Europe, the corresponding EN 62304:2006 is a harmonized standard providing a presumption of conformity. In China, it has been adopted as the recommended (not mandatory) standard YY/T 0664-2008, while in Brazil and Russia the use of standards is voluntary. For Japan (MHLW/PMDA), the standard was not yet referred to, but could be used in a premarket application to rationally explain conformity with the Essential Principles. The document does not set out a common position or an interpretation of the standard.

IMDRF final document proposing a possible framework for risk categorization of SaMD and the corresponding considerations. The category is determined by combining two factors: the significance of the information provided by the SaMD to the healthcare decision (treat or diagnose, drive clinical management, or inform clinical management) and the state of the healthcare situation or condition (critical, serious, or non-serious), resulting in four categories, I to IV, with treating or diagnosing a critical condition in the highest category (IV). The categories are relative and reflect the level of impact on the patient or public health, where accurate information provided by the SaMD is vital to avoid death, long-term disability, or other serious deterioration of health. Categorization relies on an accurate and complete SaMD definition statement. Other aspects, such as the transparency of inputs or technological characteristics, do not influence the category but inform the identification of considerations specific to a given SaMD, such as clinical evaluation, quality management, and information security.

IMDRF final document setting out a common definition of SaMD and a reminder of related key terms. SaMD is defined as software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device, and the document converges on the term SaMD in place of terms such as "standalone software." Notes to the definition state that SaMD is a medical device and includes IVD medical devices; that it is capable of running on general purpose (non-medical purpose) computing platforms; that "without being part of" means the software is not necessary for a hardware medical device to achieve its intended medical purpose; that software intended to drive a hardware medical device does not meet the definition; that SaMD may be used in combination with (e.g., as a module) or interfaced with other products, including medical devices; and that mobile apps meeting the definition are SaMD. Software used to make or maintain a device is not considered SaMD. Relevant key terms previously defined in GHTF documents are also restated.